usp expert committee
usp expert committee

2025 - 2030 Expert Committees

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Expert Committees 2025 - 2030

Our independent Volunteer Experts work together in Expert Committees, sharing their diverse knowledge and perspectives. Each Expert Committee focuses on specific areas that span the work we do to improve health. From the drugs and dietary supplements you take to the foods you eat, USP Volunteers are advancing quality standards and impacting health outcomes.

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Learn more about the work of our Expert Committees.

 

biologics icon

Biologics

Focus Areas

  • Gene therapies, gene-modified cell therapies, cellular therapies, mRNA therapies and non-oligonucleotide-based gene editing products such as CRISPR/Cas9
  • Selected general chapters that pertain to the above therapeutic classes
  • Identification and development of new tools, chapters, monographs, RS and ARMS

Expert Committee Charge

The Biologics 4 Expert Committee is responsible for advancing the development, revision, and maintenance of USP-NF General Chapters Standards in the following therapeutic categories: Gene therapies, gene-modified cell therapies, cellular therapies, mRNA therapies and non-oligonucleotide-based gene editing products such as CRISPR/Cas9. In addition to its work on General Chapters, the committee plays a pivotal role in contributing to the development of reference standards and other critical tools, including draft guidelines, Analytical Reference Materials (ARMs), and application/technical notes. These tools are essential in establishing quality benchmarks, ensuring consistency, and aligning with regulatory requirements across the pharmaceutical industry. Through its efforts, the committee addresses key challenges in the characterization, testing, and manufacturing of these complex biopharmaceuticals, ultimately supporting the development of safe, effective, and high-quality therapeutic products.

Key Issues

  • Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs/chapters/tools and develop new cell and gene therapy related chapters/tools, RS and ARMs
  • Conduct workshops relevant to areas of interest to the Expert Committee Standards Development

The latest ballot results can be found here (results can be filtered by particular ECs).

The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies: 

Roster

  • Lili Belcastro (Chair)
  • Andrew Schaefer (Vice Chair)
  • Audrey Chang
  • Basak Clements
  • Christopher Yu
  • Gael Debauve
  • Ivan Budyak
  • Kok Seong Lim
  • Lauren Drouin
  • Nate Weinstock
  • Susumu Uchiyama
  • Ying Zhang

Click here to view

Contact

Cell and Gene Therapies

Cell and Gene Therapies

Focus Areas

  • Gene therapies, gene-modified cell therapies, cellular therapies, mRNA therapies and non-oligonucleotide-based gene editing products such as CRISPR/Cas9
  • Selected general chapters that pertain to the above therapeutic classes
  • Identification and development of new tools, chapters, monographs, RS and ARMS

Expert Committee Charge

The Biologics 4 Expert Committee is responsible for advancing the development, revision, and maintenance of USP-NF General Chapters Standards in the following therapeutic categories: Gene therapies, gene-modified cell therapies, cellular therapies, mRNA therapies and non-oligonucleotide-based gene editing products such as CRISPR/Cas9. In addition to its work on General Chapters, the committee plays a pivotal role in contributing to the development of reference standards and other critical tools, including draft guidelines, Analytical Reference Materials (ARMs), and application/technical notes. These tools are essential in establishing quality benchmarks, ensuring consistency, and aligning with regulatory requirements across the pharmaceutical industry. Through its efforts, the committee addresses key challenges in the characterization, testing, and manufacturing of these complex biopharmaceuticals, ultimately supporting the development of safe, effective, and high-quality therapeutic products.

Key Issues

  • Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs/chapters/tools and develop new cell and gene therapy related chapters/tools, RS and ARMs
  • Conduct workshops relevant to areas of interest to the Expert Committee Standards Development

The latest ballot results can be found here (results can be filtered by particular ECs).

The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies: 

Roster

  • Lili Belcastro (Chair)
  • Andrew Schaefer (Vice Chair)
  • Audrey Chang
  • Basak Clements
  • Christopher Yu
  • Gael Debauve
  • Ivan Budyak
  • Kok Seong Lim
  • Lauren Drouin
  • Nate Weinstock
  • Susumu Uchiyama
  • Ying Zhang

Click here to view

Contact

Focus Areas

  • General chapters, monographs, reference standards (RS) analytical reference materials (ARMs), and other tools for synthetic, recombinant, naturally derived therapeutic peptides under 40 amino acids in length
  • Quality control of raw materials used in manufacturing of synthetic peptides and oligonucleotides
  • Selected general chapters that pertain to the above therapeutic classes
  • Modernization of outdated monographs/general chapter(s)
  • Identification and development of new tools, chapters, monographs, RS and ARMS

Expert Committee Charge

The Biologics 1 Expert Committee is responsible for advancing the development, revision, and maintenance of USP-NF General Chapters for peptides, oligonucleotides, and complex carbohydrates. In addition to its work on General Chapters, the committee plays a pivotal role in contributing to the development of reference standards and other critical tools, including draft guidelines, Analytical Reference Materials (ARMs), and application/technical notes. These tools are essential in establishing quality benchmarks, ensuring consistency, and aligning with regulatory requirements across the pharmaceutical industry. Through its efforts, the committee addresses key challenges in the characterization, testing, and manufacturing of these complex biopharmaceuticals, ultimately supporting the development of safe, effective, and high-quality therapeutic products.

Key Issues

  • Work with other Biologics Expert Committees, FDA and stakeholders to improve existing peptides oligonucleotides, and complex carbohydrates monographs/chapters/tools and develop new ones
  • Conduct workshops relevant to areas of interest to the Expert Committee
  • Transition from recombinant to synthetic drug and regulatory considerations and reference standards needed to support both forms

Standards Development

  • The latest ballot results can be found at here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Rosario Lobrutto (Chair)
  • Ved Srivastava (Vice Chair)
  • Allison Wolf
  • Antonio Ricci
  • Christian Viskov
  • George Bou-Assaf
  • Katie Duncan
  • Marc Lemaitre
  • Matthew Borer
  • Michael Berger
  • Paulo Mourao
  • Pavani Kadupu
  • Raimon Rubires

Click here to view

Contact

Therapeutic Peptides, Oligonucleotides and Complex Carbohydrates

Therapeutic Peptides, Oligonucleotides and Complex Carbohydrates

Focus Areas

  • General chapters, monographs, reference standards (RS) analytical reference materials (ARMs), and other tools for synthetic, recombinant, naturally derived therapeutic peptides under 40 amino acids in length
  • Quality control of raw materials used in manufacturing of synthetic peptides and oligonucleotides
  • Selected general chapters that pertain to the above therapeutic classes
  • Modernization of outdated monographs/general chapter(s)
  • Identification and development of new tools, chapters, monographs, RS and ARMS

Expert Committee Charge

The Biologics 1 Expert Committee is responsible for advancing the development, revision, and maintenance of USP-NF General Chapters for peptides, oligonucleotides, and complex carbohydrates. In addition to its work on General Chapters, the committee plays a pivotal role in contributing to the development of reference standards and other critical tools, including draft guidelines, Analytical Reference Materials (ARMs), and application/technical notes. These tools are essential in establishing quality benchmarks, ensuring consistency, and aligning with regulatory requirements across the pharmaceutical industry. Through its efforts, the committee addresses key challenges in the characterization, testing, and manufacturing of these complex biopharmaceuticals, ultimately supporting the development of safe, effective, and high-quality therapeutic products.

Key Issues

  • Work with other Biologics Expert Committees, FDA and stakeholders to improve existing peptides oligonucleotides, and complex carbohydrates monographs/chapters/tools and develop new ones
  • Conduct workshops relevant to areas of interest to the Expert Committee
  • Transition from recombinant to synthetic drug and regulatory considerations and reference standards needed to support both forms

Standards Development

  • The latest ballot results can be found at here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Rosario Lobrutto (Chair)
  • Ved Srivastava (Vice Chair)
  • Allison Wolf
  • Antonio Ricci
  • Christian Viskov
  • George Bou-Assaf
  • Katie Duncan
  • Marc Lemaitre
  • Matthew Borer
  • Michael Berger
  • Paulo Mourao
  • Pavani Kadupu
  • Raimon Rubires

Click here to view

Contact

Focus Areas

  • Reference standards (RS), Analytical Reference Materials (ARMs), and other tools for recombinant and naturally derived proteins, including therapeutic proteins, monoclonal antibodies, protein hormones, cytokines, enzymes, insulin, coagulation factors and complex extracts
  • Selected general chapters that pertain to the above therapeutic classes
  • Modernization of outdated monographs/general chapter(s)
  • Identification and development of new tools, chapters, monographs, RS and ARMS

Expert Committee Charge

The Biologics 2 Expert Committee is responsible for advancing the development, revision, and maintenance of USP-NF General Chapters in the following therapeutic categories: therapeutic proteins, monoclonal antibodies, protein hormones, cytokines, enzymes, and complex extracts. In addition to its work on General Chapters, the committee plays a pivotal role in contributing to the development of reference standards and other critical tools, including draft guidelines, Analytical Reference Materials (ARMs), and application/technical notes. These tools are essential in establishing quality benchmarks, ensuring consistency, and aligning with regulatory requirements across the pharmaceutical industry. Through its efforts, the committee addresses key challenges in the characterization, testing, and manufacturing of these complex biopharmaceuticals, ultimately supporting the development of safe, effective, and high-quality therapeutic products.

Key Issues

  • Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs/chapters/tools and develop new protein product chapters/tools, RS and ARMs
  • Conduct workshops relevant to areas of interest to the Expert Committee

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Kenneth Miller (Chair)
  • Fengqiang Wang (Vice Chair)
  • Amir Malek
  • Anita Krishnan
  • Berit Hansen
  • Chris Burns
  • Da Ren
  • Garret Kaess
  • Jill Crouse-Zeineddini
  • Kim Huynh-Ba
  • Lan Wang
  • Robert Mayer

Click here to view

Contact

Therapeutic Proteins

Therapeutic Proteins

Focus Areas

  • Reference standards (RS), Analytical Reference Materials (ARMs), and other tools for recombinant and naturally derived proteins, including therapeutic proteins, monoclonal antibodies, protein hormones, cytokines, enzymes, insulin, coagulation factors and complex extracts
  • Selected general chapters that pertain to the above therapeutic classes
  • Modernization of outdated monographs/general chapter(s)
  • Identification and development of new tools, chapters, monographs, RS and ARMS

Expert Committee Charge

The Biologics 2 Expert Committee is responsible for advancing the development, revision, and maintenance of USP-NF General Chapters in the following therapeutic categories: therapeutic proteins, monoclonal antibodies, protein hormones, cytokines, enzymes, and complex extracts. In addition to its work on General Chapters, the committee plays a pivotal role in contributing to the development of reference standards and other critical tools, including draft guidelines, Analytical Reference Materials (ARMs), and application/technical notes. These tools are essential in establishing quality benchmarks, ensuring consistency, and aligning with regulatory requirements across the pharmaceutical industry. Through its efforts, the committee addresses key challenges in the characterization, testing, and manufacturing of these complex biopharmaceuticals, ultimately supporting the development of safe, effective, and high-quality therapeutic products.

Key Issues

  • Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs/chapters/tools and develop new protein product chapters/tools, RS and ARMs
  • Conduct workshops relevant to areas of interest to the Expert Committee

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Kenneth Miller (Chair)
  • Fengqiang Wang (Vice Chair)
  • Amir Malek
  • Anita Krishnan
  • Berit Hansen
  • Chris Burns
  • Da Ren
  • Garret Kaess
  • Jill Crouse-Zeineddini
  • Kim Huynh-Ba
  • Lan Wang
  • Robert Mayer

Click here to view

Contact

Focus Areas

  • Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs/chapters/tools and develop new ones
  • Selected general chapters that pertain to the above therapeutic classes
  • Identification and development of new tools, chapters, monographs, RS and ARMS

Expert Committee Charge

The Biologics 3 Expert Committee is responsible for advancing the development, revision, and maintenance of USP-NF General Chapters for vaccines across diverse therapeutic areas, including infectious diseases, cancer immunotherapies, and emerging vaccine platforms like mRNA and nucleic acid-based technologies. In addition to its work on General Chapters, the committee plays a pivotal role in contributing to the development of reference standards and other critical tools, including draft guidelines, Analytical Reference Materials (ARMs), and application/technical notes. These tools are essential in establishing quality benchmarks, ensuring consistency, and aligning with regulatory requirements across the pharmaceutical industry. Through its efforts, the committee addresses key challenges in the characterization, testing, and manufacturing of these complex biopharmaceuticals, ultimately supporting the development of safe, effective, and high-quality therapeutic products.

Key Issues

  • Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs/chapters/tools and develop new vaccine related chapters/tools, RS and ARMs
  • Conduct workshops relevant to areas of interest to the Expert Committee Related Expert Bodies

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies:

Roster

  • Mark Van Ooij (Chair)
  • Lawrence Thompson (Vice Chair)
  • Bruce Carpick
  • Cristiana Campa
  • Earl Zablackis
  • Jan Falcke
  • Ned Mozier
  • Neeraj Kaushal
  • Paul Stickings
  • Peter Lowry
  • Philip Ramsey
  • Veera Dheenadhayalan

Click here to view

Contact

Vaccines

Vaccines

Focus Areas

  • Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs/chapters/tools and develop new ones
  • Selected general chapters that pertain to the above therapeutic classes
  • Identification and development of new tools, chapters, monographs, RS and ARMS

Expert Committee Charge

The Biologics 3 Expert Committee is responsible for advancing the development, revision, and maintenance of USP-NF General Chapters for vaccines across diverse therapeutic areas, including infectious diseases, cancer immunotherapies, and emerging vaccine platforms like mRNA and nucleic acid-based technologies. In addition to its work on General Chapters, the committee plays a pivotal role in contributing to the development of reference standards and other critical tools, including draft guidelines, Analytical Reference Materials (ARMs), and application/technical notes. These tools are essential in establishing quality benchmarks, ensuring consistency, and aligning with regulatory requirements across the pharmaceutical industry. Through its efforts, the committee addresses key challenges in the characterization, testing, and manufacturing of these complex biopharmaceuticals, ultimately supporting the development of safe, effective, and high-quality therapeutic products.

Key Issues

  • Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs/chapters/tools and develop new vaccine related chapters/tools, RS and ARMs
  • Conduct workshops relevant to areas of interest to the Expert Committee Related Expert Bodies

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies:

Roster

  • Mark Van Ooij (Chair)
  • Lawrence Thompson (Vice Chair)
  • Bruce Carpick
  • Cristiana Campa
  • Earl Zablackis
  • Jan Falcke
  • Ned Mozier
  • Neeraj Kaushal
  • Paul Stickings
  • Peter Lowry
  • Philip Ramsey
  • Veera Dheenadhayalan

Click here to view

Contact

dietary supplements and foods

Dietary Supplements & Herbal Medicines, Food Ingredients

Focus Areas

  • Botanical dietary supplement ingredient and product monographs
  • Herbal medicinal ingredient monographs

Expert Committee Charge

The Botanical Dietary Supplements and Herbal Medicines Expert Committee is responsible for the development of new and revision of existing monographs and their associated reference materials for botanical dietary ingredients and supplement products and herbal medicine ingredients. The Expert Committee will address U.S. as well as global standards.

Key Issues

  • Work with stakeholders to develop new and improve existing botanical dietary supplement and herbal medicine monographs
  • Work with stakeholders to modernize existing botanical drug monographs
  • Modernize methods for analysis of articles of botanical origin as appropriate

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Thomas Brendler (Chair)
  • Holly Johnson (Vice Chair)
  • Cecilia Beatriz Dobrecky
  • De An Guo
  • Ed J Kennelly
  • Iffet Tatli Cankaya
  • James Kababick
  • Josef Brinckmann
  • Pilar Pais
  • Ranjan Mitra
  • Stefan Gafner
  • Steven Dentali
  • Tien Do

Click here to view

Contact

  • Kit Goldman, Ph.D., Senior Director, Dietary Supplements and Herbal Medicines - Science, kit.goldman@usp.org
  • Nandakumara Sarma, Ph.D., Dietary Supplements and Herbal Medicines, Director, dns@usp.org
  • Julie Clyman, Expert Committee Manager, julie.clyman@usp.org
Botanical Dietary Supplements and Herbal Medicines

Botanical Dietary Supplements and Herbal Medicines

Focus Areas

  • Botanical dietary supplement ingredient and product monographs
  • Herbal medicinal ingredient monographs

Expert Committee Charge

The Botanical Dietary Supplements and Herbal Medicines Expert Committee is responsible for the development of new and revision of existing monographs and their associated reference materials for botanical dietary ingredients and supplement products and herbal medicine ingredients. The Expert Committee will address U.S. as well as global standards.

Key Issues

  • Work with stakeholders to develop new and improve existing botanical dietary supplement and herbal medicine monographs
  • Work with stakeholders to modernize existing botanical drug monographs
  • Modernize methods for analysis of articles of botanical origin as appropriate

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Thomas Brendler (Chair)
  • Holly Johnson (Vice Chair)
  • Cecilia Beatriz Dobrecky
  • De An Guo
  • Ed J Kennelly
  • Iffet Tatli Cankaya
  • James Kababick
  • Josef Brinckmann
  • Pilar Pais
  • Ranjan Mitra
  • Stefan Gafner
  • Steven Dentali
  • Tien Do

Click here to view

Contact

  • Kit Goldman, Ph.D., Senior Director, Dietary Supplements and Herbal Medicines - Science, kit.goldman@usp.org
  • Nandakumara Sarma, Ph.D., Dietary Supplements and Herbal Medicines, Director, dns@usp.org
  • Julie Clyman, Expert Committee Manager, julie.clyman@usp.org

Focus Areas

  • Ascertain that candidates for USP dietary supplements monograph development do not present serious risk to health or other public health concerns, prior to developing USP standards for the dietary supplement ingredient. 

Expert Committee Charge

  • Determine the admissibility of dietary supplement articles for USP quality monograph development according to the Guideline for the Admission of Dietary Ingredients to the USP–NF Monograph Development Process.
  • Monitor the literature periodically for any new information that may alter the admission status of a dietary ingredient/supplement already published in USP-NF or previously not admitted for monograph development.
  • Contribute to projects related to safety assessment of dietary supplements that may require their input and any other matters related to safety of herbal medicine ingredients published in the USP’s herbal medicines compendium (HMC) according to the USP Guidelines.
  • Advise the Food Ingredients EC on matters related to the safety of food ingredients and setting limits for undesirable constituents. 

Key Issues

  • Evaluating safety and toxicological information for a variety of dietary ingredients, including plants, plant extracts, probiotics, proteins, amino acids, and oils.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Amy Roe (Chair)
  • Richard Ko (Vice Chair)
  • Bill Gurley
  • Deval Patel
  • Igor Koturbash
  • James Griffiths
  • Jo Barnes
  • Marie-Eve Boyte
  • Mary Hardy
  • Paula Gardiner
  • Richard Van Breeman
  • Zehra Kilic

Click here to view

Contact

Dietary Supplements Admission Evaluation & Labeling

Dietary Supplements Admission Evaluation & Labeling

Focus Areas

  • Ascertain that candidates for USP dietary supplements monograph development do not present serious risk to health or other public health concerns, prior to developing USP standards for the dietary supplement ingredient. 

Expert Committee Charge

  • Determine the admissibility of dietary supplement articles for USP quality monograph development according to the Guideline for the Admission of Dietary Ingredients to the USP–NF Monograph Development Process.
  • Monitor the literature periodically for any new information that may alter the admission status of a dietary ingredient/supplement already published in USP-NF or previously not admitted for monograph development.
  • Contribute to projects related to safety assessment of dietary supplements that may require their input and any other matters related to safety of herbal medicine ingredients published in the USP’s herbal medicines compendium (HMC) according to the USP Guidelines.
  • Advise the Food Ingredients EC on matters related to the safety of food ingredients and setting limits for undesirable constituents. 

Key Issues

  • Evaluating safety and toxicological information for a variety of dietary ingredients, including plants, plant extracts, probiotics, proteins, amino acids, and oils.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Amy Roe (Chair)
  • Richard Ko (Vice Chair)
  • Bill Gurley
  • Deval Patel
  • Igor Koturbash
  • James Griffiths
  • Jo Barnes
  • Marie-Eve Boyte
  • Mary Hardy
  • Paula Gardiner
  • Richard Van Breeman
  • Zehra Kilic

Click here to view

Contact

Focus Areas

  • Food Ingredients, food additives, food colors, Generally Recognized as Safe (GRAS) substances, and processing aids
  • Dietary proteins, herb and spices, high value oils, and other substances at risk of adulteration
  • Functional ingredients and special nutritionals intended to support human health

Expert Committee Charge

The Food Ingredients Expert Committee is responsible for the development and revision of Food Chemicals Codex (FCC) documentary standards and guidance documents as well as associated analytical materials.

Key Issues

  • Developing fit-for-purpose standards and solutions for food ingredients, with a focus on safe foods for vulnerable populations
  • Creating advanced methods and guidelines to support standards for prioritized novel and emerging ingredients.
  • Addressing adulteration and contamination issues in food ingredients, including elemental impurities, residual solvents, pesticides, mycotoxins, and microbial contaminants
  • Advocating for the committee's work and collaborating with the FDA and other global regulatory bodies.

Standards Development

  • Review and comment on the proposals and revisions in the FCC Forum.
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each FCC and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • James Brooks (Chair)
  • Stephan Walch (Vice Chair)
  • Dana Krueger
  • Hong You
  • John Clos
  • Liangli (Lucy) Yu
  • Maciej Chichlowski
  • Priscilla Zawislak
  • Richard Cantrill
  • Robin Churchill
  • Sneh Bhandari
  • Wee Sim Choo
  • Yoko Uematsu

Click here to view

Contact

Food Ingredients

Food Ingredients

Focus Areas

  • Food Ingredients, food additives, food colors, Generally Recognized as Safe (GRAS) substances, and processing aids
  • Dietary proteins, herb and spices, high value oils, and other substances at risk of adulteration
  • Functional ingredients and special nutritionals intended to support human health

Expert Committee Charge

The Food Ingredients Expert Committee is responsible for the development and revision of Food Chemicals Codex (FCC) documentary standards and guidance documents as well as associated analytical materials.

Key Issues

  • Developing fit-for-purpose standards and solutions for food ingredients, with a focus on safe foods for vulnerable populations
  • Creating advanced methods and guidelines to support standards for prioritized novel and emerging ingredients.
  • Addressing adulteration and contamination issues in food ingredients, including elemental impurities, residual solvents, pesticides, mycotoxins, and microbial contaminants
  • Advocating for the committee's work and collaborating with the FDA and other global regulatory bodies.

Standards Development

  • Review and comment on the proposals and revisions in the FCC Forum.
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each FCC and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • James Brooks (Chair)
  • Stephan Walch (Vice Chair)
  • Dana Krueger
  • Hong You
  • John Clos
  • Liangli (Lucy) Yu
  • Maciej Chichlowski
  • Priscilla Zawislak
  • Richard Cantrill
  • Robin Churchill
  • Sneh Bhandari
  • Wee Sim Choo
  • Yoko Uematsu

Click here to view

Contact

Focus Areas

  • Non-botanical (vitamins, minerals, amino acids, enzymes, oils, proteins, probiotics and other materials) dietary supplement ingredient and product monographs Expert Committee Charge
  • The Non-Botanical Dietary Supplements Expert Committee is responsible for the development of new and modernization/revision of existing monographs and their associated reference materials for non-botanical dietary supplement ingredients and products.

Key Issues

  • Developing standards for non-botanical dietary ingredients and supplements.
  • Creating modern analytical methods for compendial use.
  • Covering various classes of ingredients such as amino acids, carbohydrates, mineral salts, mineral complexes, oils, fatty acids, lipids, probiotics, dietary proteins, small molecules, and vitamins.
  • Addressing dosage forms including tablets, capsules (hard shell and softgels), gummies (chewable gels), and performance testing (dissolution, disintegration), as well as manufacturing and formulation aspects, emulsions, and nanomaterials.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies:

Roster

  • Raimar Loebenberg (Chair)
  • Jean Schoeni (Vice Chair)
  • Catherine Rimmer
  • Christian Sood
  • Christina Szabo
  • Ed Shneyvas
  • Erik Fuglseth
  • Hiroko Suzuki
  • Jinchuan Yang
  • Kurt Young
  • Shauna Roman
  • Tammy Blakemore
  • Yao Lu
  • Zhengfei Lu

Click here to view

Contact

Non-Botanical Dietary Supplements

Non-Botanical Dietary Supplements

Focus Areas

  • Non-botanical (vitamins, minerals, amino acids, enzymes, oils, proteins, probiotics and other materials) dietary supplement ingredient and product monographs Expert Committee Charge
  • The Non-Botanical Dietary Supplements Expert Committee is responsible for the development of new and modernization/revision of existing monographs and their associated reference materials for non-botanical dietary supplement ingredients and products.

Key Issues

  • Developing standards for non-botanical dietary ingredients and supplements.
  • Creating modern analytical methods for compendial use.
  • Covering various classes of ingredients such as amino acids, carbohydrates, mineral salts, mineral complexes, oils, fatty acids, lipids, probiotics, dietary proteins, small molecules, and vitamins.
  • Addressing dosage forms including tablets, capsules (hard shell and softgels), gummies (chewable gels), and performance testing (dissolution, disintegration), as well as manufacturing and formulation aspects, emulsions, and nanomaterials.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies:

Roster

  • Raimar Loebenberg (Chair)
  • Jean Schoeni (Vice Chair)
  • Catherine Rimmer
  • Christian Sood
  • Christina Szabo
  • Ed Shneyvas
  • Erik Fuglseth
  • Hiroko Suzuki
  • Jinchuan Yang
  • Kurt Young
  • Shauna Roman
  • Tammy Blakemore
  • Yao Lu
  • Zhengfei Lu

Click here to view

Contact

excipients

Excipients

Focus Areas

  • Physical Analysis
  • Chemical Analysis
  • GMP/GDP/Supplier Qualification/Importation

Expert Committee Charge

The Excipient General Chapters Expert Committee is charged with enhancing the quality and safety of excipients used in pharmaceutical applications by addressing contamination and adulteration risks, developing and improving methods by using up-to-date and advanced technologies, and developing comprehensive standards.

Key Issues

Working with Stakeholders to address the following key issues:

  • Developing chapters to support the identification, characterization, supply, and distribution of excipients from development to pharmaceutical use.
  • Introducing/Updating excipient chapters to reduce contamination and adulteration risks.
  • Developing advanced methods to determine compositional variability throughout the excipient lifecycle.
  • Updating and improving USP-NF standards with the aim to introduce advanced characterization and detection methods to help better control excipient variability concerns (physical, chemical, microbiological, etc.) that impact drug performance that are efficiently suited for regulatory purposes and environmentally friendly.
  • Updating <1074> Excipient Biological Safety Evaluation Guidelines
  • Collaborating with PDG and global partners in harmonization of monographs and chapters
  • Advocating for the committee's work and collaborating with the FDA and other global regulatory bodies.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Richard Creekmore (Chair)
  • Shaukat Ali (Vice Chair)
  • Alexa Smith
  • Brian Carlin
  • Isra Dmour
  • Kenneth Rosenberg
  • Mary Kate Houck
  • Mary Lee Ciolkowski
  • Pradeep Dabhi
  • Richard Moreton
  • Stephen Andruski
  • Tony Carpanzano
  • Yaozuo Yuan

Click here to view

Government Liaisons

  • Chunqiang Guo, FDA
  • Matthew Stark, FDA
  • Jin Zhang, FDA

Contact

  • Catherine Sheehan, DRSc, MS., MS., Senior Director – Foods and Excipients, cxs@usp.org
  • Kimberly Harris, MPA, Expert Committee Manager – Excipients, Kimberly.Harris@usp.org
Excipient Chapters

Excipient Chapters

Focus Areas

  • Physical Analysis
  • Chemical Analysis
  • GMP/GDP/Supplier Qualification/Importation

Expert Committee Charge

The Excipient General Chapters Expert Committee is charged with enhancing the quality and safety of excipients used in pharmaceutical applications by addressing contamination and adulteration risks, developing and improving methods by using up-to-date and advanced technologies, and developing comprehensive standards.

Key Issues

Working with Stakeholders to address the following key issues:

  • Developing chapters to support the identification, characterization, supply, and distribution of excipients from development to pharmaceutical use.
  • Introducing/Updating excipient chapters to reduce contamination and adulteration risks.
  • Developing advanced methods to determine compositional variability throughout the excipient lifecycle.
  • Updating and improving USP-NF standards with the aim to introduce advanced characterization and detection methods to help better control excipient variability concerns (physical, chemical, microbiological, etc.) that impact drug performance that are efficiently suited for regulatory purposes and environmentally friendly.
  • Updating <1074> Excipient Biological Safety Evaluation Guidelines
  • Collaborating with PDG and global partners in harmonization of monographs and chapters
  • Advocating for the committee's work and collaborating with the FDA and other global regulatory bodies.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Richard Creekmore (Chair)
  • Shaukat Ali (Vice Chair)
  • Alexa Smith
  • Brian Carlin
  • Isra Dmour
  • Kenneth Rosenberg
  • Mary Kate Houck
  • Mary Lee Ciolkowski
  • Pradeep Dabhi
  • Richard Moreton
  • Stephen Andruski
  • Tony Carpanzano
  • Yaozuo Yuan

Click here to view

Government Liaisons

  • Chunqiang Guo, FDA
  • Matthew Stark, FDA
  • Jin Zhang, FDA

Contact

  • Catherine Sheehan, DRSc, MS., MS., Senior Director – Foods and Excipients, cxs@usp.org
  • Kimberly Harris, MPA, Expert Committee Manager – Excipients, Kimberly.Harris@usp.org

Focus Areas

  • Simple inorganic/ organic compounds
  • Lipids
  • Essential and Fixed Oils
  • Fats
  • Minerals

Expert Committee Charge

The Excipient Monograph 1 Expert Committee is charged with enhancing the quality and safety of excipients used in pharmaceutical applications by addressing contamination and adulteration risks, developing and improving methods by using up-to-date and advanced technologies, and developing comprehensive standards and solutions.

Key Issues

  • Developing compendial excipient monographs lacking USP-NF Standards.
  • Revising outdated, non-selective, and non-specific identification and assay methods to reduce contamination and adulteration risks.
  • Updating and improving USP-NF standards with the aim to introduce advanced characterization and detection methods to help better control excipient variability concerns (physical, chemical, microbiological, etc.) that impact drug performance that are efficiently suited for regulatory purposes and environmentally friendly.
  • Exploring opportunities to introduce solutions via emerging standards.
  • Collaborating with PDG and global partners in harmonization of monographs and chapters.
  • Advocating for the committee's work and collaborating with the FDA and other global regulatory bodies.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Vivek Dave (Chair)
  • Dominic Moore (Vice Chair)
  • Charles Vesey
  • Elena Bogatcheva
  • Haichen Nie
  • Hiteshkumar Patel
  • Jiasheng Tu
  • Jin Zhao
  • Medha Joshi
  • Miquel Mir
  • Raymond Chen
  • Roger Pak
  • Yuhua Wang

Click here to view

Government Liaisons

  • Megha Barot, FDA
  • Bini Matthew, FDA
  • Steve Wolfgang, FDA

Contact

  • Catherine Sheehan, DRSc, MS., MS., Senior Director – Foods and Excipients, cxs@usp.org
  • Kimberly Harris, MPA, Expert Committee Manager – Excipients, Kimberly.Harris@usp.org
Excipient Monograph 1

Excipient Monograph 1

Focus Areas

  • Simple inorganic/ organic compounds
  • Lipids
  • Essential and Fixed Oils
  • Fats
  • Minerals

Expert Committee Charge

The Excipient Monograph 1 Expert Committee is charged with enhancing the quality and safety of excipients used in pharmaceutical applications by addressing contamination and adulteration risks, developing and improving methods by using up-to-date and advanced technologies, and developing comprehensive standards and solutions.

Key Issues

  • Developing compendial excipient monographs lacking USP-NF Standards.
  • Revising outdated, non-selective, and non-specific identification and assay methods to reduce contamination and adulteration risks.
  • Updating and improving USP-NF standards with the aim to introduce advanced characterization and detection methods to help better control excipient variability concerns (physical, chemical, microbiological, etc.) that impact drug performance that are efficiently suited for regulatory purposes and environmentally friendly.
  • Exploring opportunities to introduce solutions via emerging standards.
  • Collaborating with PDG and global partners in harmonization of monographs and chapters.
  • Advocating for the committee's work and collaborating with the FDA and other global regulatory bodies.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Vivek Dave (Chair)
  • Dominic Moore (Vice Chair)
  • Charles Vesey
  • Elena Bogatcheva
  • Haichen Nie
  • Hiteshkumar Patel
  • Jiasheng Tu
  • Jin Zhao
  • Medha Joshi
  • Miquel Mir
  • Raymond Chen
  • Roger Pak
  • Yuhua Wang

Click here to view

Government Liaisons

  • Megha Barot, FDA
  • Bini Matthew, FDA
  • Steve Wolfgang, FDA

Contact

  • Catherine Sheehan, DRSc, MS., MS., Senior Director – Foods and Excipients, cxs@usp.org
  • Kimberly Harris, MPA, Expert Committee Manager – Excipients, Kimberly.Harris@usp.org

Focus Areas

  • Natural, synthetic, and semisynthetic polymers
  • Cellulosics
  • Waxes
  • Clays

Expert Committee Charge

The Excipient Monograph 2 Expert Committee is charged with enhancing the quality and safety of excipients used in pharmaceutical applications by addressing contamination and adulteration risks, developing and improving methods by using up-to-date and advanced technologies, and developing comprehensive standards and solutions.

Key Issues

  • Developing compendial excipient monographs lacking USP-NF Standards.
  • Revising outdated, non-selective, and non-specific identification and assay methods to reduce contamination and adulteration risks.
  • Updating and improving USP-NF standards with the aim to introduce advanced characterization and detection methods to help better control excipient variability concerns (physical, chemical, microbiological, etc.) that impact drug performance that are efficiently suited for regulatory purposes and environmentally friendly.
  • Exploring opportunities to introduce solutions via emerging standards.
  • Collaborating with PDG and global partners in harmonization of monographs and chapters
  • Advocating for the committee's work and collaborating with the FDA and other global regulatory bodies.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here. 

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Barbara Serr (Chair)
  • Fan Wu (Vice Chair)
  • Barthelemy Luc Demeule
  • Eric Munson
  • Harsh Chauhan
  • Huimin Sun
  • Manish Rane
  • Nigel Langley
  • Otilia Koo
  • Timothy Frigo
  • Ting Wang
  • Whitney Moro
  • Yixin Ren

Click here to view

Government Liaisons

  • Hudson Roth, FDA
  • Steve Wolfgang, FDA
  • Jin Zhang, FDA
  • Yuda Zong, FDA

Contact

  • Catherine Sheehan, DRSc, MS., MS., Senior Director – Foods and Excipients, cxs@usp.org
  • Kimberly Harris, MPA, Expert Committee Manager - Excipients, Kimberly.Harris@usp.org
Excipient Monograph 2

Excipient Monograph 2

Focus Areas

  • Natural, synthetic, and semisynthetic polymers
  • Cellulosics
  • Waxes
  • Clays

Expert Committee Charge

The Excipient Monograph 2 Expert Committee is charged with enhancing the quality and safety of excipients used in pharmaceutical applications by addressing contamination and adulteration risks, developing and improving methods by using up-to-date and advanced technologies, and developing comprehensive standards and solutions.

Key Issues

  • Developing compendial excipient monographs lacking USP-NF Standards.
  • Revising outdated, non-selective, and non-specific identification and assay methods to reduce contamination and adulteration risks.
  • Updating and improving USP-NF standards with the aim to introduce advanced characterization and detection methods to help better control excipient variability concerns (physical, chemical, microbiological, etc.) that impact drug performance that are efficiently suited for regulatory purposes and environmentally friendly.
  • Exploring opportunities to introduce solutions via emerging standards.
  • Collaborating with PDG and global partners in harmonization of monographs and chapters
  • Advocating for the committee's work and collaborating with the FDA and other global regulatory bodies.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here. 

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Barbara Serr (Chair)
  • Fan Wu (Vice Chair)
  • Barthelemy Luc Demeule
  • Eric Munson
  • Harsh Chauhan
  • Huimin Sun
  • Manish Rane
  • Nigel Langley
  • Otilia Koo
  • Timothy Frigo
  • Ting Wang
  • Whitney Moro
  • Yixin Ren

Click here to view

Government Liaisons

  • Hudson Roth, FDA
  • Steve Wolfgang, FDA
  • Jin Zhang, FDA
  • Yuda Zong, FDA

Contact

  • Catherine Sheehan, DRSc, MS., MS., Senior Director – Foods and Excipients, cxs@usp.org
  • Kimberly Harris, MPA, Expert Committee Manager - Excipients, Kimberly.Harris@usp.org
usp general chapters

General Chapters

Focus Areas

  • Analytical Chemistry:
    • Analytical techniques such as chromatography (HPLC, GC), spectroscopy (UV-Vis, IR, NMR), and elemental analysis.
    • Sample preparation, separation, and detection methods.
  • Automation of Analytical Techniques:
    • Automated methods for analytical processes, such as titrimetry, chromatography, and spectroscopy.
    • Familiarity with robotic systems, software automation, and process optimization.
  • Spectroscopic Techniques:
    • Various spectroscopic methods (e.g., UV-Vis, IR, NMR, fluorescence) for qualitative and quantitative analysis.
    • Spectral data and identification of compounds.
  • Process Analytical Technology (PAT):
    • PAT principles and applications.
    • Real-time monitoring and control into manufacturing processes.
  • Life-Cycle Approach of Analytical Technologies:
    • Life cycle of analytical methods, from development to validation, implementation, and maintenance.
    • Method robustness, stability, and adaptability over time.
  • Digital Applications in Analytical Technology:
    • Data analytics, machine learning, and artificial intelligence applied to analytical data.
    • Digital tools for data visualization, pattern recognition, and predictive modeling.
  • Data Integrity and Data Governance:
    • Data accuracy, security, and compliance with regulatory requirements.
    • Data management protocols and maintaining audit trails.
  • GC Reference Standard Development:
    • Reference standards for gas chromatography (GC) methods.
    • Purity, stability, and traceability of reference materials.
  • Nanomaterial Analytical Characterization:
    • Characterizing nanomaterials (e.g., nanoparticles, nanocomposites).
    • Size, shape, surface properties, and stability analysis.
  • Impurity Characterization:
    • Impurities (organic and inorganic) in pharmaceuticals, chemicals, or materials.
  • Analytical Techniques for Complex Generics:
    • Analytical methods specific to complex generic products.
    • Formulation variations, excipients, and degradation products.
  • Risk-Based Approaches:
    • Risk assessment methodologies to prioritize analytical efforts.
    • Quality attributes and potential risks in product development and manufacturing.

Expert Committee Charge

The Chemical Analysis Expert Committee focuses on developing and updating USP standards and guidance related to chemical analysis methods. This includes various analytical techniques such as chromatography, spectroscopy, and wet chemistry. The committee also supports and evolves existing general chapters that provide essential standards and guidance for users engaged in regulatory sciences.

Key Issues

  • Pharmaceutical Waters: Evaluating and recommending standards, practices, and addressing challenges in the production, quality control, and regulatory requirements of pharmaceutical waters (PW, WFI, etc.).
  • Environmental Impact: Assessing and recommending strategies to reduce the environmental footprint of the pharmaceutical industry.
  • Quality Management Systems (QMS): Enhancing the effectiveness of Quality Management Systems within the pharmaceutical industry.
  • Mutagenic Impurities: Evaluating risks and developing recommendations to control and minimize mutagenic impurities in pharmaceutical products.
  • Light Scattering Techniques: Exploring and advancing the use of light scattering techniques in pharmaceutical analysis.
  • Chromatographic Methodologies: Enhancing chromatographic practices, exploring innovative techniques, and optimizing their use in pharmaceutical analysis.
  • Chemometric Techniques: Advancing the application of chemometric techniques in pharmaceutical development and quality control.
  • Ion Chromatography (IC): Evaluating and advancing the application of ion chromatography in pharmaceutical analysis.
  • Elemental Impurities: Assessing and providing recommendations for managing elemental impurities in pharmaceutical products.
  • Nitrosamine Impurities: Evaluating and addressing risks associated with nitrosamine impurities in pharmaceutical products.
  • Organic Impurities: Providing recommendations for identifying, quantifying, and controlling organic impurities in drug substances and products.
  • Process Analytical Technology (PAT): Advancing the application of PAT in pharmaceutical manufacturing.
  • Quantitative NMR (qNMR): Advancing the application of qNMR for quantitative analysis in the pharmaceutical industry.
  • Solid-state NMR (ssNMR): Advancing the application of ssNMR for analyzing solid pharmaceutical forms.
  • Data Integrity: Enhancing practices related to data integrity in pharmaceutical operations.
  • Spectroscopic Techniques: Advancing the use of spectroscopic techniques in pharmaceutical analysis.
  • Titration Methodologies: Enhancing titration practices and exploring innovative techniques for accurate quantification in pharmaceutical products.
  • Wet Chemistry Techniques: Advancing the application of wet chemistry techniques in pharmaceutical analysis.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Anthony Bevilacqua (Chair)
  • Oscar Quattrocchi (Vice Chair)
  • Aaron Urbas
  • Amy Barker
  • Andrew Lincoln
  • Bette Monnot-Chase
  • Fang Lu
  • John Hinshaw
  • Kannan Jakkan
  • Kevin Arthur Swiss
  • Landon Greene
  • Nancy Lewen
  • Nuno Matos
  • Shakil Sait
  • Suresh Kumar
  • Yang Liu

Click here to view

Contact

Chemical Analysis

Chemical Analysis

Focus Areas

  • Analytical Chemistry:
    • Analytical techniques such as chromatography (HPLC, GC), spectroscopy (UV-Vis, IR, NMR), and elemental analysis.
    • Sample preparation, separation, and detection methods.
  • Automation of Analytical Techniques:
    • Automated methods for analytical processes, such as titrimetry, chromatography, and spectroscopy.
    • Familiarity with robotic systems, software automation, and process optimization.
  • Spectroscopic Techniques:
    • Various spectroscopic methods (e.g., UV-Vis, IR, NMR, fluorescence) for qualitative and quantitative analysis.
    • Spectral data and identification of compounds.
  • Process Analytical Technology (PAT):
    • PAT principles and applications.
    • Real-time monitoring and control into manufacturing processes.
  • Life-Cycle Approach of Analytical Technologies:
    • Life cycle of analytical methods, from development to validation, implementation, and maintenance.
    • Method robustness, stability, and adaptability over time.
  • Digital Applications in Analytical Technology:
    • Data analytics, machine learning, and artificial intelligence applied to analytical data.
    • Digital tools for data visualization, pattern recognition, and predictive modeling.
  • Data Integrity and Data Governance:
    • Data accuracy, security, and compliance with regulatory requirements.
    • Data management protocols and maintaining audit trails.
  • GC Reference Standard Development:
    • Reference standards for gas chromatography (GC) methods.
    • Purity, stability, and traceability of reference materials.
  • Nanomaterial Analytical Characterization:
    • Characterizing nanomaterials (e.g., nanoparticles, nanocomposites).
    • Size, shape, surface properties, and stability analysis.
  • Impurity Characterization:
    • Impurities (organic and inorganic) in pharmaceuticals, chemicals, or materials.
  • Analytical Techniques for Complex Generics:
    • Analytical methods specific to complex generic products.
    • Formulation variations, excipients, and degradation products.
  • Risk-Based Approaches:
    • Risk assessment methodologies to prioritize analytical efforts.
    • Quality attributes and potential risks in product development and manufacturing.

Expert Committee Charge

The Chemical Analysis Expert Committee focuses on developing and updating USP standards and guidance related to chemical analysis methods. This includes various analytical techniques such as chromatography, spectroscopy, and wet chemistry. The committee also supports and evolves existing general chapters that provide essential standards and guidance for users engaged in regulatory sciences.

Key Issues

  • Pharmaceutical Waters: Evaluating and recommending standards, practices, and addressing challenges in the production, quality control, and regulatory requirements of pharmaceutical waters (PW, WFI, etc.).
  • Environmental Impact: Assessing and recommending strategies to reduce the environmental footprint of the pharmaceutical industry.
  • Quality Management Systems (QMS): Enhancing the effectiveness of Quality Management Systems within the pharmaceutical industry.
  • Mutagenic Impurities: Evaluating risks and developing recommendations to control and minimize mutagenic impurities in pharmaceutical products.
  • Light Scattering Techniques: Exploring and advancing the use of light scattering techniques in pharmaceutical analysis.
  • Chromatographic Methodologies: Enhancing chromatographic practices, exploring innovative techniques, and optimizing their use in pharmaceutical analysis.
  • Chemometric Techniques: Advancing the application of chemometric techniques in pharmaceutical development and quality control.
  • Ion Chromatography (IC): Evaluating and advancing the application of ion chromatography in pharmaceutical analysis.
  • Elemental Impurities: Assessing and providing recommendations for managing elemental impurities in pharmaceutical products.
  • Nitrosamine Impurities: Evaluating and addressing risks associated with nitrosamine impurities in pharmaceutical products.
  • Organic Impurities: Providing recommendations for identifying, quantifying, and controlling organic impurities in drug substances and products.
  • Process Analytical Technology (PAT): Advancing the application of PAT in pharmaceutical manufacturing.
  • Quantitative NMR (qNMR): Advancing the application of qNMR for quantitative analysis in the pharmaceutical industry.
  • Solid-state NMR (ssNMR): Advancing the application of ssNMR for analyzing solid pharmaceutical forms.
  • Data Integrity: Enhancing practices related to data integrity in pharmaceutical operations.
  • Spectroscopic Techniques: Advancing the use of spectroscopic techniques in pharmaceutical analysis.
  • Titration Methodologies: Enhancing titration practices and exploring innovative techniques for accurate quantification in pharmaceutical products.
  • Wet Chemistry Techniques: Advancing the application of wet chemistry techniques in pharmaceutical analysis.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Anthony Bevilacqua (Chair)
  • Oscar Quattrocchi (Vice Chair)
  • Aaron Urbas
  • Amy Barker
  • Andrew Lincoln
  • Bette Monnot-Chase
  • Fang Lu
  • John Hinshaw
  • Kannan Jakkan
  • Kevin Arthur Swiss
  • Landon Greene
  • Nancy Lewen
  • Nuno Matos
  • Shakil Sait
  • Suresh Kumar
  • Yang Liu

Click here to view

Contact

Focus Areas

  • Dosage Forms
  • Performance Testing
  • Medical Devices
  • Nanotechnology
  • Ophthalmic Preparations
  • Particulate Matter
  • Capsules
  • Injections and Implants
  • Topical and Mucosal Products
  • Continuous Manufacturing
  • Semisolid Dosage Forms
  • Veterinary Solubility
  • Verification Testing
  • Filters and Membranes

Expert Committee Charge

The Dosage Form Expert Committee focuses on developing and updating of guidance related to pharmaceutical dosage forms. This includes dosage form performance, physical characterization, default expectations, and developmental aspects.

Key Issues

  • Pharmaceutical Dosage Forms (<1151>): Enhancing practices, guidelines, and standards for pharmaceutical dosage forms.
  • Dermal Dosage Forms: Improving design, development, testing, and regulatory compliance of dermal dosage forms.
  • Inhalation Dosage Forms: Enhancing practices for inhalation dosage forms, including design, development, testing, and regulatory compliance.
  • Oral Dosage Forms: Advancing practices related to oral dosage forms, including design, development, testing, and regulatory compliance.
  • Performance Testing: Improving practices for performance testing of pharmaceutical dosage forms, including dissolution, disintegration, and drug release.
  • Data Analysis: Enhancing data analysis practices in pharmaceutical research, development, and manufacturing.
  • Medical (Drug) Devices: Improving practices for the design, development, testing, and regulatory compliance of medical devices used to deliver pharmaceutical products.
  • Nanotechnology: Advancing the application of nanotechnology in pharmaceutical research, development, and manufacturing.
  • Ophthalmic Preparations (<771>): Enhancing standards and practices for the formulation, testing, and regulatory compliance of ophthalmic preparations.
  • Particulate Matter in Injections (<788>): Improving standards and practices for controlling, detecting, and quantifying particulate matter in injectable pharmaceutical products.
  • Capsules: Enhancing practices for the design, development, testing, and regulatory compliance of capsule dosage forms.
  • Injections and Implanted Drug Products: Improving practices for injectable and implanted drug products, including design, development, testing, and regulatory compliance.
  • Topical and Transdermal Drug Products: Enhancing practices for topical and transdermal drug products, including design, development, testing, and regulatory compliance.
  • Mucosal Drug Products: Improving practices for mucosal drug products, including design, development, testing, and regulatory compliance.
  • Continuous Manufacturing: Enhancing practices for the implementation and optimization of continuous manufacturing in pharmaceutical production.
  • Nanomaterials: Advancing the use, characterization, and regulatory compliance of nanomaterials in pharmaceutical research, development, and manufacturing.
  • Performance Testing for Semisolid Dosage Forms: Improving practices for testing and assessing semisolid dosage forms.
  • Solubility Criteria for Veterinary Drugs: Establishing solubility criteria specifically for veterinary drugs.
  • Performance Verification Testing: Enhancing practices for performance verification testing in pharmaceutical manufacturing and quality control.
  • Resuspendability (<1003>): Improving practices for the resuspendability of pharmaceutical suspensions.
  • Visual Inspection of Parenterals: Enhancing practices for the visual inspection of parenteral pharmaceutical products.
  • Particulate Matter: Silicone Oil: Improving practices for detecting, quantifying, and controlling silicone oil as particulate matter in pharmaceutical products, particularly in parenteral formulations.
  • Filters and Membranes: Enhancing practices for the selection, testing, and regulatory compliance of filters and membranes used in pharmaceutical manufacturing.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Kevin Warner (Chair)
  • Colin Minchom
  • Dama Venugopala Rao
  • Gregory Amidon
  • Hiro Sakagami
  • Ishai Nir
  • Jolyon Mitchell
  • Kimberly Dunn
  • Mahesh Chavan Patil
  • Matthias Wacker
  • Mehran Yazdanian
  • Praveen Hiremath
  • Rick Watson
  • Sarika Namjoshi
  • Stanley Kwok
  • Susan Cady
  • Tom Tice

Click here to view

Contact

  • Margareth R. C. Marques, Ph. D., Senior Principal Scientist - General Chapters, mrm@usp.org
  • Kimberly McKinney, MBA, Expert Committee Manager, kam@usp.org
Dosage Forms

Dosage Forms

Focus Areas

  • Dosage Forms
  • Performance Testing
  • Medical Devices
  • Nanotechnology
  • Ophthalmic Preparations
  • Particulate Matter
  • Capsules
  • Injections and Implants
  • Topical and Mucosal Products
  • Continuous Manufacturing
  • Semisolid Dosage Forms
  • Veterinary Solubility
  • Verification Testing
  • Filters and Membranes

Expert Committee Charge

The Dosage Form Expert Committee focuses on developing and updating of guidance related to pharmaceutical dosage forms. This includes dosage form performance, physical characterization, default expectations, and developmental aspects.

Key Issues

  • Pharmaceutical Dosage Forms (<1151>): Enhancing practices, guidelines, and standards for pharmaceutical dosage forms.
  • Dermal Dosage Forms: Improving design, development, testing, and regulatory compliance of dermal dosage forms.
  • Inhalation Dosage Forms: Enhancing practices for inhalation dosage forms, including design, development, testing, and regulatory compliance.
  • Oral Dosage Forms: Advancing practices related to oral dosage forms, including design, development, testing, and regulatory compliance.
  • Performance Testing: Improving practices for performance testing of pharmaceutical dosage forms, including dissolution, disintegration, and drug release.
  • Data Analysis: Enhancing data analysis practices in pharmaceutical research, development, and manufacturing.
  • Medical (Drug) Devices: Improving practices for the design, development, testing, and regulatory compliance of medical devices used to deliver pharmaceutical products.
  • Nanotechnology: Advancing the application of nanotechnology in pharmaceutical research, development, and manufacturing.
  • Ophthalmic Preparations (<771>): Enhancing standards and practices for the formulation, testing, and regulatory compliance of ophthalmic preparations.
  • Particulate Matter in Injections (<788>): Improving standards and practices for controlling, detecting, and quantifying particulate matter in injectable pharmaceutical products.
  • Capsules: Enhancing practices for the design, development, testing, and regulatory compliance of capsule dosage forms.
  • Injections and Implanted Drug Products: Improving practices for injectable and implanted drug products, including design, development, testing, and regulatory compliance.
  • Topical and Transdermal Drug Products: Enhancing practices for topical and transdermal drug products, including design, development, testing, and regulatory compliance.
  • Mucosal Drug Products: Improving practices for mucosal drug products, including design, development, testing, and regulatory compliance.
  • Continuous Manufacturing: Enhancing practices for the implementation and optimization of continuous manufacturing in pharmaceutical production.
  • Nanomaterials: Advancing the use, characterization, and regulatory compliance of nanomaterials in pharmaceutical research, development, and manufacturing.
  • Performance Testing for Semisolid Dosage Forms: Improving practices for testing and assessing semisolid dosage forms.
  • Solubility Criteria for Veterinary Drugs: Establishing solubility criteria specifically for veterinary drugs.
  • Performance Verification Testing: Enhancing practices for performance verification testing in pharmaceutical manufacturing and quality control.
  • Resuspendability (<1003>): Improving practices for the resuspendability of pharmaceutical suspensions.
  • Visual Inspection of Parenterals: Enhancing practices for the visual inspection of parenteral pharmaceutical products.
  • Particulate Matter: Silicone Oil: Improving practices for detecting, quantifying, and controlling silicone oil as particulate matter in pharmaceutical products, particularly in parenteral formulations.
  • Filters and Membranes: Enhancing practices for the selection, testing, and regulatory compliance of filters and membranes used in pharmaceutical manufacturing.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Kevin Warner (Chair)
  • Colin Minchom
  • Dama Venugopala Rao
  • Gregory Amidon
  • Hiro Sakagami
  • Ishai Nir
  • Jolyon Mitchell
  • Kimberly Dunn
  • Mahesh Chavan Patil
  • Matthias Wacker
  • Mehran Yazdanian
  • Praveen Hiremath
  • Rick Watson
  • Sarika Namjoshi
  • Stanley Kwok
  • Susan Cady
  • Tom Tice

Click here to view

Contact

  • Margareth R. C. Marques, Ph. D., Senior Principal Scientist - General Chapters, mrm@usp.org
  • Kimberly McKinney, MBA, Expert Committee Manager, kam@usp.org

Focus Areas

  • Instrumental Determination of Color
  • Crystal/Microscopy
  • Particles and Image Analysis
  • Powders
  • Rheology
  • Solutions
  • Osmolality and Osmolarity
  • Solubility Measurement

Expert Committee Charge 

The Materials Physical Properties Characterization Expert Committee focuses on developing and refining analytical methods for the physical characterization of powders, liquids, and compounded or formulated drug products. This includes standards and guidelines for analytical procedures for the material’s physical properties characterization and quality control, including input and in-process materials used in the manufacturing of a drug product and/or its components.

Key Issues

  • Instrumental Determination of Color: Advancing the use of instrumental techniques for color determination in pharmaceutical products.
  • Microscopy Techniques: Enhancing the use of microscopy for analyzing and characterizing crystalline structures in pharmaceutical products.
  • Image Analysis of Particles: Advancing image analysis techniques for characterizing and quantifying particles in pharmaceutical products.
  • Powder Analysis: Improving methodologies for the analysis, characterization, and handling of powders in pharmaceutical applications.
  • Rheological Techniques: Advancing the application of rheological techniques in pharmaceutical research, development, and manufacturing.
  • Solution Preparation and Stability: Enhancing practices related to the preparation, testing, and stability of solutions in pharmaceutical formulations.
  • Osmolality and Osmolarity Measurement: Advancing methodologies for measuring and controlling osmolality and osmolarity in pharmaceutical products.
  • Solubility Measurement: Improving methodologies for accurately measuring solubility in pharmaceutical research and development to ensure product efficacy, bioavailability, and regulatory compliance.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Eloise Welfare (Chair)
  • Calvin Sun (Vice Chair)
  • Bruno Hancock
  • David Goldfarb
  • Jack Saad
  • Manpreet Kaur
  • Mario Hubert
  • Marsh Whiteman
  • Martin Coffey
  • Matthew Jackson
  • Rich Meury
  • Tapan Das
  • Timothy Bochula

Click here to view

Contact

Materials Physical Properties Characterization

Materials Physical Properties Characterization

Focus Areas

  • Instrumental Determination of Color
  • Crystal/Microscopy
  • Particles and Image Analysis
  • Powders
  • Rheology
  • Solutions
  • Osmolality and Osmolarity
  • Solubility Measurement

Expert Committee Charge 

The Materials Physical Properties Characterization Expert Committee focuses on developing and refining analytical methods for the physical characterization of powders, liquids, and compounded or formulated drug products. This includes standards and guidelines for analytical procedures for the material’s physical properties characterization and quality control, including input and in-process materials used in the manufacturing of a drug product and/or its components.

Key Issues

  • Instrumental Determination of Color: Advancing the use of instrumental techniques for color determination in pharmaceutical products.
  • Microscopy Techniques: Enhancing the use of microscopy for analyzing and characterizing crystalline structures in pharmaceutical products.
  • Image Analysis of Particles: Advancing image analysis techniques for characterizing and quantifying particles in pharmaceutical products.
  • Powder Analysis: Improving methodologies for the analysis, characterization, and handling of powders in pharmaceutical applications.
  • Rheological Techniques: Advancing the application of rheological techniques in pharmaceutical research, development, and manufacturing.
  • Solution Preparation and Stability: Enhancing practices related to the preparation, testing, and stability of solutions in pharmaceutical formulations.
  • Osmolality and Osmolarity Measurement: Advancing methodologies for measuring and controlling osmolality and osmolarity in pharmaceutical products.
  • Solubility Measurement: Improving methodologies for accurately measuring solubility in pharmaceutical research and development to ensure product efficacy, bioavailability, and regulatory compliance.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Eloise Welfare (Chair)
  • Calvin Sun (Vice Chair)
  • Bruno Hancock
  • David Goldfarb
  • Jack Saad
  • Manpreet Kaur
  • Mario Hubert
  • Marsh Whiteman
  • Martin Coffey
  • Matthew Jackson
  • Rich Meury
  • Tapan Das
  • Timothy Bochula

Click here to view

Contact

Focus Areas

  • Endotoxins and Pyrogens
  • Microbial Control and Sterility Assurance
  • Bioburden Testing
  • Rapid Microbial Methods
  • Microbiological Issues in Dietary Supplements and Food Ingredients

Expert Committee Charge

The Microbiology Expert Committee focuses on developing and updating USP–NF standards related to microbiological quality for both nonsterile and sterile products, encompassing pharmaceuticals, biologics, compounded preparations, dietary supplements, and food ingredients.

Key Issues

  • Endotoxins and Pyrogens: Enhancing detection, control, and mitigation of endotoxins and pyrogens in pharmaceutical products.
  • Microbial Control and Sterility Assurance: Improving practices and methodologies for microbial control and sterility assurance in pharmaceutical manufacturing.
  • Bioburden Testing: Optimizing methodologies for bioburden testing to ensure accuracy, consistency, and regulatory compliance in pharmaceutical manufacturing.
  • Rapid Microbial Methods (RMM): Advancing the application of rapid microbial methods in pharmaceutical quality control and manufacturing.
  • Microbiological Issues in Dietary Supplements and Food Ingredients: Addressing microbiological concerns to ensure the safety, quality, and regulatory compliance of dietary supplements and food ingredients.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Ed Tidswell (Chair)
  • Allison Scott
  • Brandye Michaels
  • David Roesti
  • Debbie Roberts
  • Friedrich von Wintzingerode
  • Ibrahim Aman Khan
  • Ibrahim Khalil
  • Jay Bolden
  • Jessica Vencill Hankins
  • Laurie Boyd
  • Liliana Gamboa
  • Marianne Larsen
  • Peter Nissen
  • Phil Duncanson
  • Sebastian Hannemann
  • Thomas Cullen
  • Victoria Abbott-Ozug
  • Vijay Kishore Somara
  • Yiling Fan

Click here to view

Contact 

  • Huiping Tu, Ph.D., Senior Principal Scientist – Science-General Chapters, hpt@usp.org
  • Kimberly McKinney, MBA, Expert Committee Manager, kam@usp.org
Microbiology

Microbiology

Focus Areas

  • Endotoxins and Pyrogens
  • Microbial Control and Sterility Assurance
  • Bioburden Testing
  • Rapid Microbial Methods
  • Microbiological Issues in Dietary Supplements and Food Ingredients

Expert Committee Charge

The Microbiology Expert Committee focuses on developing and updating USP–NF standards related to microbiological quality for both nonsterile and sterile products, encompassing pharmaceuticals, biologics, compounded preparations, dietary supplements, and food ingredients.

Key Issues

  • Endotoxins and Pyrogens: Enhancing detection, control, and mitigation of endotoxins and pyrogens in pharmaceutical products.
  • Microbial Control and Sterility Assurance: Improving practices and methodologies for microbial control and sterility assurance in pharmaceutical manufacturing.
  • Bioburden Testing: Optimizing methodologies for bioburden testing to ensure accuracy, consistency, and regulatory compliance in pharmaceutical manufacturing.
  • Rapid Microbial Methods (RMM): Advancing the application of rapid microbial methods in pharmaceutical quality control and manufacturing.
  • Microbiological Issues in Dietary Supplements and Food Ingredients: Addressing microbiological concerns to ensure the safety, quality, and regulatory compliance of dietary supplements and food ingredients.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Ed Tidswell (Chair)
  • Allison Scott
  • Brandye Michaels
  • David Roesti
  • Debbie Roberts
  • Friedrich von Wintzingerode
  • Ibrahim Aman Khan
  • Ibrahim Khalil
  • Jay Bolden
  • Jessica Vencill Hankins
  • Laurie Boyd
  • Liliana Gamboa
  • Marianne Larsen
  • Peter Nissen
  • Phil Duncanson
  • Sebastian Hannemann
  • Thomas Cullen
  • Victoria Abbott-Ozug
  • Vijay Kishore Somara
  • Yiling Fan

Click here to view

Contact 

  • Huiping Tu, Ph.D., Senior Principal Scientist – Science-General Chapters, hpt@usp.org
  • Kimberly McKinney, MBA, Expert Committee Manager, kam@usp.org

Focus Areas

  • Glass Containers
  • Elastomer Materials
  • Plastic Containers
  • Metallic Containers
  • Biocompatibility Testing
  • Extractables and Leachables Testing
  • Good Distribution Practices
  • Packaging Sustainability
  • Container Closure Integrity
  • Particle Control
  • Packaging Performance Testing

Expert Committee Charge

The Packaging and Distribution Expert Committee focuses on developing and updating of guidance related to pharmaceutical packaging. This includes packaging systems and their materials of construction, packaging terminology, and proper storage and distribution practices for compendial articles.

Key Issues

  • Glass Containers: Enhancing practices for the selection, testing, and qualification of glass containers in pharmaceutical packaging.
  • Elastomer Materials: Advancing the use, testing, and qualification of elastomer materials in pharmaceutical packaging and manufacturing systems to ensure safety, compatibility, and regulatory compliance.
  • Plastic Containers: Improving the use, testing, and qualification of plastic containers in pharmaceutical packaging.
  • Metallic Containers: Enhancing the use, testing, and qualification of metallic containers in pharmaceutical packaging.
  • Biocompatibility Testing: Improving practices for biocompatibility testing of materials used in pharmaceutical packaging and manufacturing systems.
  • Extractables and Leachables (E&L) Testing: Enhancing practices for E&L testing of materials used in pharmaceutical packaging and manufacturing systems.
  • Good Distribution Practices (GDP): Improving practices related to the distribution of pharmaceutical products.
  • Packaging Sustainability: Advancing sustainable practices in pharmaceutical packaging.
  • Container Closure Integrity (CCI): Enhancing practices to ensure the integrity of container closure systems in pharmaceutical packaging.
  • Particle Control on Packaging Components: Improving practices for the control, detection, and prevention of particulate contamination in pharmaceutical packaging components.
  • Packaging Performance Testing: Enhancing practices for the testing and validation of pharmaceutical packaging performance.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Renaud Janssen (Chair)
  • Bettine Boltres
  • Brandon Zurawlow
  • Chris Anderson
  • Dennis Jenke
  • Douglas Kiehl
  • Eric Hill
  • Fangfang Zhang
  • Jennifer Roark
  • John Fontaine
  • Michael Eakins
  • Ramon Vazquez
  • Søren Kåre Nielsen
  • Wen Yuan

Click here to view

Contact

  • Desmond Hunt, Ph.D., Senior Principal Scientist - General Chapters, dgh@usp.org
  • Kimberly McKinney, MBA, Expert Committee Manager, kam@usp.org
Packaging and Distribution

Packaging and Distribution

Focus Areas

  • Glass Containers
  • Elastomer Materials
  • Plastic Containers
  • Metallic Containers
  • Biocompatibility Testing
  • Extractables and Leachables Testing
  • Good Distribution Practices
  • Packaging Sustainability
  • Container Closure Integrity
  • Particle Control
  • Packaging Performance Testing

Expert Committee Charge

The Packaging and Distribution Expert Committee focuses on developing and updating of guidance related to pharmaceutical packaging. This includes packaging systems and their materials of construction, packaging terminology, and proper storage and distribution practices for compendial articles.

Key Issues

  • Glass Containers: Enhancing practices for the selection, testing, and qualification of glass containers in pharmaceutical packaging.
  • Elastomer Materials: Advancing the use, testing, and qualification of elastomer materials in pharmaceutical packaging and manufacturing systems to ensure safety, compatibility, and regulatory compliance.
  • Plastic Containers: Improving the use, testing, and qualification of plastic containers in pharmaceutical packaging.
  • Metallic Containers: Enhancing the use, testing, and qualification of metallic containers in pharmaceutical packaging.
  • Biocompatibility Testing: Improving practices for biocompatibility testing of materials used in pharmaceutical packaging and manufacturing systems.
  • Extractables and Leachables (E&L) Testing: Enhancing practices for E&L testing of materials used in pharmaceutical packaging and manufacturing systems.
  • Good Distribution Practices (GDP): Improving practices related to the distribution of pharmaceutical products.
  • Packaging Sustainability: Advancing sustainable practices in pharmaceutical packaging.
  • Container Closure Integrity (CCI): Enhancing practices to ensure the integrity of container closure systems in pharmaceutical packaging.
  • Particle Control on Packaging Components: Improving practices for the control, detection, and prevention of particulate contamination in pharmaceutical packaging components.
  • Packaging Performance Testing: Enhancing practices for the testing and validation of pharmaceutical packaging performance.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Renaud Janssen (Chair)
  • Bettine Boltres
  • Brandon Zurawlow
  • Chris Anderson
  • Dennis Jenke
  • Douglas Kiehl
  • Eric Hill
  • Fangfang Zhang
  • Jennifer Roark
  • John Fontaine
  • Michael Eakins
  • Ramon Vazquez
  • Søren Kåre Nielsen
  • Wen Yuan

Click here to view

Contact

  • Desmond Hunt, Ph.D., Senior Principal Scientist - General Chapters, dgh@usp.org
  • Kimberly McKinney, MBA, Expert Committee Manager, kam@usp.org

Focus Areas

  • Analytical Procedure Life Cycle
  • Instrument and System Qualification
  • Balances
  • Measurement
  • Metrology
  • Product Performance Verification
  • Total Error & Measurement Uncertainty (MU)
  • Volumetric Apparatus

Expert Committee Charge

The Pharmaceutical Analysis Lifecycle Expert Committee focuses on developing and updating of USP standards and guidance for material characterization. This includes Analytical Chemistry, Pharmaceutical Science, Material Science, Quality Control, Validation and Verification, Method Development and Optimization, and Data Integrity and Good Laboratory Practices (GLP).

Key Issues

  • Analytical Procedure Life Cycle (<1220>): Advancing the implementation of the analytical procedure life cycle approach as outlined in USP <1220>.
  • Analytical Instrument and System Qualification: Enhancing practices and methodologies for the qualification of analytical instruments and systems to ensure accuracy, reliability, and regulatory compliance.
  • Balances: Improving practices related to the use, calibration, and qualification of balances in pharmaceutical laboratories.
  • Measurement Practices: Enhancing methodologies related to measurement across pharmaceutical research, development, and manufacturing.
  • Metrology: Advancing metrological practices in pharmaceutical research, development, and manufacturing.
  • Product Performance Verification: Improving practices related to the verification of pharmaceutical product performance throughout its lifecycle.
  • Total Error & Measurement Uncertainty (MU): Advancing the understanding and application of total error and measurement uncertainty in pharmaceutical analysis.
  • Volumetric Apparatus: Enhancing practices related to the use, calibration, and qualification of volumetric apparatus in pharmaceutical laboratories.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Jaime Marach (Chair)
  • Mary Lee Jane Weitzel (Vice Chair)
  • Amanda Guiraldelli Mahr
  • Chris Burgess
  • Jean-François Dierick
  • Jean-Marc Roussel
  • Jennifer Bates
  • Joachim Ermer
  • Pierre Lebrun
  • Tao Jiang

Click here to view

Contact

Pharmaceutical Analysis Lifecycle and Data Science

Pharmaceutical Analysis Lifecycle and Data Science

Focus Areas

  • Analytical Procedure Life Cycle
  • Instrument and System Qualification
  • Balances
  • Measurement
  • Metrology
  • Product Performance Verification
  • Total Error & Measurement Uncertainty (MU)
  • Volumetric Apparatus

Expert Committee Charge

The Pharmaceutical Analysis Lifecycle Expert Committee focuses on developing and updating of USP standards and guidance for material characterization. This includes Analytical Chemistry, Pharmaceutical Science, Material Science, Quality Control, Validation and Verification, Method Development and Optimization, and Data Integrity and Good Laboratory Practices (GLP).

Key Issues

  • Analytical Procedure Life Cycle (<1220>): Advancing the implementation of the analytical procedure life cycle approach as outlined in USP <1220>.
  • Analytical Instrument and System Qualification: Enhancing practices and methodologies for the qualification of analytical instruments and systems to ensure accuracy, reliability, and regulatory compliance.
  • Balances: Improving practices related to the use, calibration, and qualification of balances in pharmaceutical laboratories.
  • Measurement Practices: Enhancing methodologies related to measurement across pharmaceutical research, development, and manufacturing.
  • Metrology: Advancing metrological practices in pharmaceutical research, development, and manufacturing.
  • Product Performance Verification: Improving practices related to the verification of pharmaceutical product performance throughout its lifecycle.
  • Total Error & Measurement Uncertainty (MU): Advancing the understanding and application of total error and measurement uncertainty in pharmaceutical analysis.
  • Volumetric Apparatus: Enhancing practices related to the use, calibration, and qualification of volumetric apparatus in pharmaceutical laboratories.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Jaime Marach (Chair)
  • Mary Lee Jane Weitzel (Vice Chair)
  • Amanda Guiraldelli Mahr
  • Chris Burgess
  • Jean-François Dierick
  • Jean-Marc Roussel
  • Jennifer Bates
  • Joachim Ermer
  • Pierre Lebrun
  • Tao Jiang

Click here to view

Contact

Focus Areas

  • Bioassay Validation <1033>
  • Bioassay Analysis <1034>
  • Bioassay Design and Development <Chapter 1032>
  • Content Uniformity for Large Sample Sizes

Expert Committee Charge

The General Chapters–Statistics Expert Committee is responsible for providing statistical support for other Expert Committees in their development and approval of monographs, general chapters, and reference materials.

Key Issues

  • Biological Assay Validation <1033>: Enhancing practices for the validation of biological assays in pharmaceutical and biopharmaceutical development and manufacturing.
  • Analysis of Biological Assays <1034>: Improving practices for the statistical analysis and interpretation of biological assays as outlined in USP <1034>.
  • Design and Development of Biological Assays <1032>: Enhancing practices for the design, development, and optimization of biological assays as outlined in USP <1032>.
  • Content Uniformity for Large Sample Sizes: Improving practices for assessing content uniformity in pharmaceutical products, particularly for large sample sizes.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Charles Tan (Chair)
  • Walter Hauck (Vice Chair)
  • Ann Yellowlees
  • Charles Miller
  • Eric Rozet
  • Gregory Chen
  • Jia Liu
  • Katie Domermuth
  • Paul Faya
  • Perceval Sondag

Click here to view

Contact

Statistics

Statistics

Focus Areas

  • Bioassay Validation <1033>
  • Bioassay Analysis <1034>
  • Bioassay Design and Development <Chapter 1032>
  • Content Uniformity for Large Sample Sizes

Expert Committee Charge

The General Chapters–Statistics Expert Committee is responsible for providing statistical support for other Expert Committees in their development and approval of monographs, general chapters, and reference materials.

Key Issues

  • Biological Assay Validation <1033>: Enhancing practices for the validation of biological assays in pharmaceutical and biopharmaceutical development and manufacturing.
  • Analysis of Biological Assays <1034>: Improving practices for the statistical analysis and interpretation of biological assays as outlined in USP <1034>.
  • Design and Development of Biological Assays <1032>: Enhancing practices for the design, development, and optimization of biological assays as outlined in USP <1032>.
  • Content Uniformity for Large Sample Sizes: Improving practices for assessing content uniformity in pharmaceutical products, particularly for large sample sizes.

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Roster

  • Charles Tan (Chair)
  • Walter Hauck (Vice Chair)
  • Ann Yellowlees
  • Charles Miller
  • Eric Rozet
  • Gregory Chen
  • Jia Liu
  • Katie Domermuth
  • Paul Faya
  • Perceval Sondag

Click here to view

Contact

health care quality and safety

Healthcare Quality & Safety

Focus Areas

  • General Chapters on compounding and handling of sterile and nonsterile preparations, including hazardous and investigational drugs
  • Tailored solutions to support implementation of practices that promote quality compounding formulations
  • Select priority public health impact monographs for sterile and nonsterile compounded preparations

Expert Committee Charge

The Compounding Expert Committee will develop new and revise existing compounding-related general chapters describing quality and practice standards for compounding sterile and nonsterile preparation. The Expert Committee will develop compounded preparation monographs containing formulations for both human and veterinary patients.

Key Issues

  • Sterile and Nonsterile Compounding
  • Veterinary Compounding
  • Handling Hazardous drugs
  • Aseptic Technique
  • Technologies for Compounding
  • Quality Assurance
  • Testing of Compounded Preparations

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Brenda Jensen (Chair)
  • Edmund Elder (Vice Chair)
  • Deborah Larison
  • Diego Marro
  • George Smith
  • Gigi Davidson
  • Glen Gard
  • Hudson Polonini
  • Jessica Hawkins
  • Kathleen Kane
  • Kelley Reece
  • Kevin Hansen
  • Lisa Ashworth
  • Mark Wiencek
  • Melissa Messick
  • Paul Baker
  • Rick Rhoads
  • Vanessa Pinheiro

Click here to view

Contact

CompoundingSL@usp.org

  • Brian Serumaga, Director, Healthcare Quality and Safety Standards BNS@USP.org
  • Presha Regmi, Expert Committee Manager, Healthcare Quality & Safety Presha.Regmi@USP.org
  • Farah Towfic, Senior Director, Healthcare Quality & Safety Center of Excellence Farah.Towfic@USP.org
Compounding

Compounding

Focus Areas

  • General Chapters on compounding and handling of sterile and nonsterile preparations, including hazardous and investigational drugs
  • Tailored solutions to support implementation of practices that promote quality compounding formulations
  • Select priority public health impact monographs for sterile and nonsterile compounded preparations

Expert Committee Charge

The Compounding Expert Committee will develop new and revise existing compounding-related general chapters describing quality and practice standards for compounding sterile and nonsterile preparation. The Expert Committee will develop compounded preparation monographs containing formulations for both human and veterinary patients.

Key Issues

  • Sterile and Nonsterile Compounding
  • Veterinary Compounding
  • Handling Hazardous drugs
  • Aseptic Technique
  • Technologies for Compounding
  • Quality Assurance
  • Testing of Compounded Preparations

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Brenda Jensen (Chair)
  • Edmund Elder (Vice Chair)
  • Deborah Larison
  • Diego Marro
  • George Smith
  • Gigi Davidson
  • Glen Gard
  • Hudson Polonini
  • Jessica Hawkins
  • Kathleen Kane
  • Kelley Reece
  • Kevin Hansen
  • Lisa Ashworth
  • Mark Wiencek
  • Melissa Messick
  • Paul Baker
  • Rick Rhoads
  • Vanessa Pinheiro

Click here to view

Contact

CompoundingSL@usp.org

  • Brian Serumaga, Director, Healthcare Quality and Safety Standards BNS@USP.org
  • Presha Regmi, Expert Committee Manager, Healthcare Quality & Safety Presha.Regmi@USP.org
  • Farah Towfic, Senior Director, Healthcare Quality & Safety Center of Excellence Farah.Towfic@USP.org

Focus Areas

  • Clinical Decision Support (CDS) tools refinement and enhancement
  • Data quality optimization within healthcare systems
  • Healthcare technology tools and practices advancement

Expert Committee Charge

The Health Information & Technology Expert (HI&T) Committee will explore the development of quality standards, tools, and solutions to advance technology in healthcare and optimize healthcare practices. This includes leveraging the diverse expertise of committee members to address patient and public health needs.

Key Issues

  • Medication barcodes
  • Adverse drug event documentation within electronic health records
  • Exchange of medication information across healthcare technology
  • Establishing standardized identifiers for non-manufactured medications

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Leslie Lenert (Chair)
  • Charlene Hope (Vice Chair)
  • Catherine Graeff
  • Chris Chandler
  • Clark Butler
  • David Aguero
  • Leanne Murray
  • Richard Parrish
  • Van Do

Click here to view

Contact

Healthinfotech@usp.org

  • Brian Serumaga, Director, Healthcare Quality and Safety Standards BNS@USP.org
  • Presha Regmi, Expert Committee Manager, Healthcare Quality & Safety Presha.Regmi@USP.org
  • Farah Towfic, Senior Director, Healthcare Quality & Safety Center of Excellence Farah.Towfic@USP.org
Healthcare Information and Technology (HI&T)

Healthcare Information and Technology (HI&T)

Focus Areas

  • Clinical Decision Support (CDS) tools refinement and enhancement
  • Data quality optimization within healthcare systems
  • Healthcare technology tools and practices advancement

Expert Committee Charge

The Health Information & Technology Expert (HI&T) Committee will explore the development of quality standards, tools, and solutions to advance technology in healthcare and optimize healthcare practices. This includes leveraging the diverse expertise of committee members to address patient and public health needs.

Key Issues

  • Medication barcodes
  • Adverse drug event documentation within electronic health records
  • Exchange of medication information across healthcare technology
  • Establishing standardized identifiers for non-manufactured medications

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Leslie Lenert (Chair)
  • Charlene Hope (Vice Chair)
  • Catherine Graeff
  • Chris Chandler
  • Clark Butler
  • David Aguero
  • Leanne Murray
  • Richard Parrish
  • Van Do

Click here to view

Contact

Healthinfotech@usp.org

  • Brian Serumaga, Director, Healthcare Quality and Safety Standards BNS@USP.org
  • Presha Regmi, Expert Committee Manager, Healthcare Quality & Safety Presha.Regmi@USP.org
  • Farah Towfic, Senior Director, Healthcare Quality & Safety Center of Excellence Farah.Towfic@USP.org

Focus Areas

  • Drug classification
  • Safe medication use
  • Health literacy
  • Nomenclature Guidelines
  • Drug Substance Pronunciation
  • Prescription Container and Product labeling requirements
  • Monograph titles

Expert Committee Charge

The Healthcare Safety Quality and Nomenclature (HSQN) Expert Committee will develop, strengthen, revise, and promote adoption of healthcare quality standards and solutions that address the use and access of medications that impact practitioners and manufacturers. This includes the review of monograph titles elaborated in the USP Nomenclature Guidelines and develop and revise general chapters that focus on nomenclature, labeling and medication safety topics.

Key Issues

  • Drug Classification Systems
    • USP Medicare Model Guidelines (USP MMG)
    • USP Drug Classification (USP DC)
  • Medication Safety
    • <1066> Physical Environments that Promote Safe Medication Use
    • <1265> Written Prescription Drug Information Guidelines
  • Nomenclature
    • Nomenclature regulations and policies
    • <1121> Nomenclature
  • Labeling
    • <7> Labeling
    • <17> Prescription Container Labeling
    • <1091> Labeling of Inactive Ingredients
  • Health Literacy

Standards Development

The latest ballot results can be found here (results can be filtered by particular ECs).

The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Melody Ryan (Chair)
  • Michelle Then (Vice Chair)
  • Aleksandra (Sasha) Beselman
  • Bernard Appiah
  • Carlos Cezar Flores Vidotti
  • Carmen Gonzalez
  • Danial Baker
  • Joan Galbraith
  • Jovonne Williams
  • Keith Hecht
  • Maged Sharaf
  • Marwa Noureldin
  • Mary Baker
  • Paria Sanaty Zadeh
  • Pratixa Patel
  • Srikanth Sridhar
  • Timothy Albertson
  • Wesley Byerly

Click here to view

Contact

  • Brian Serumaga, Director, Healthcare Quality and Safety Standards BNS@USP.org
  • Presha Regmi, Expert Committee Manager, Healthcare Quality & Safety Presha.Regmi@USP.org
  • Farah Towfic, Senior Director, Healthcare Quality & Safety Center of Excellence Farah.Towfic@USP.org
Healthcare Safety, Quality & Nomenclature (HSQN)

Healthcare Safety, Quality & Nomenclature (HSQN)

Focus Areas

  • Drug classification
  • Safe medication use
  • Health literacy
  • Nomenclature Guidelines
  • Drug Substance Pronunciation
  • Prescription Container and Product labeling requirements
  • Monograph titles

Expert Committee Charge

The Healthcare Safety Quality and Nomenclature (HSQN) Expert Committee will develop, strengthen, revise, and promote adoption of healthcare quality standards and solutions that address the use and access of medications that impact practitioners and manufacturers. This includes the review of monograph titles elaborated in the USP Nomenclature Guidelines and develop and revise general chapters that focus on nomenclature, labeling and medication safety topics.

Key Issues

  • Drug Classification Systems
    • USP Medicare Model Guidelines (USP MMG)
    • USP Drug Classification (USP DC)
  • Medication Safety
    • <1066> Physical Environments that Promote Safe Medication Use
    • <1265> Written Prescription Drug Information Guidelines
  • Nomenclature
    • Nomenclature regulations and policies
    • <1121> Nomenclature
  • Labeling
    • <7> Labeling
    • <17> Prescription Container Labeling
    • <1091> Labeling of Inactive Ingredients
  • Health Literacy

Standards Development

The latest ballot results can be found here (results can be filtered by particular ECs).

The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Melody Ryan (Chair)
  • Michelle Then (Vice Chair)
  • Aleksandra (Sasha) Beselman
  • Bernard Appiah
  • Carlos Cezar Flores Vidotti
  • Carmen Gonzalez
  • Danial Baker
  • Joan Galbraith
  • Jovonne Williams
  • Keith Hecht
  • Maged Sharaf
  • Marwa Noureldin
  • Mary Baker
  • Paria Sanaty Zadeh
  • Pratixa Patel
  • Srikanth Sridhar
  • Timothy Albertson
  • Wesley Byerly

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Contact

  • Brian Serumaga, Director, Healthcare Quality and Safety Standards BNS@USP.org
  • Presha Regmi, Expert Committee Manager, Healthcare Quality & Safety Presha.Regmi@USP.org
  • Farah Towfic, Senior Director, Healthcare Quality & Safety Center of Excellence Farah.Towfic@USP.org

Focus Areas

  • Pharmacogenomics
  • Software as a Medical Device
  • Nomenclature and labeling considerations for Software as a Medical Device and Pharmacogenomics

Expert Committee Charge

The Personalized Medicine Expert Committee will explore and develop standards and related solutions for medications and treatments tailored to meet the unique needs of individual patients.

Key Issues

  • Standards and related products that support the adoption of pharmacogenomics considerations for personalized healthcare
  • Developing frameworks for clinical evidence generation in order to support the evaluation of the quality, safety and effectiveness of digital therapeutics
  • Health equity, usability and access to personalized medicines
  • Establishing standardized identifiers of quality personalized medicine products (e.g. Digital therapeutics, Pharmacogenomics tests, digital diagnostics, etc) to encourage commercialization, prescribing, coverage and reimbursement with current and future healthcare delivery systems Related Expert Bodies

Standards Development

The latest ballot results can be found here (results can be filtered by particular ECs).

The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Sara Rogers (Chair)
  • Gustavo Torres de Souza (Vice Chair)
  • Christine Formea
  • Kelly Caudle
  • Otito Iwuchukwu
  • Rachel Elsey
  • Raymond Lorenz
  • Simran Maggo
  • Thu Chan

Click here to view

Contact

  • Brian Serumaga, Director, Healthcare Quality and Safety Standards BNS@USP.org
  • Presha Regmi, Expert Committee Manager, Healthcare Quality & Safety Presha.Regmi@USP.org
  • Farah Towfic, Senior Director, Healthcare Quality & Safety Center of Excellence Farah.Towfic@USP.org
Personalized Medicine

Personalized Medicine

Focus Areas

  • Pharmacogenomics
  • Software as a Medical Device
  • Nomenclature and labeling considerations for Software as a Medical Device and Pharmacogenomics

Expert Committee Charge

The Personalized Medicine Expert Committee will explore and develop standards and related solutions for medications and treatments tailored to meet the unique needs of individual patients.

Key Issues

  • Standards and related products that support the adoption of pharmacogenomics considerations for personalized healthcare
  • Developing frameworks for clinical evidence generation in order to support the evaluation of the quality, safety and effectiveness of digital therapeutics
  • Health equity, usability and access to personalized medicines
  • Establishing standardized identifiers of quality personalized medicine products (e.g. Digital therapeutics, Pharmacogenomics tests, digital diagnostics, etc) to encourage commercialization, prescribing, coverage and reimbursement with current and future healthcare delivery systems Related Expert Bodies

Standards Development

The latest ballot results can be found here (results can be filtered by particular ECs).

The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Sara Rogers (Chair)
  • Gustavo Torres de Souza (Vice Chair)
  • Christine Formea
  • Kelly Caudle
  • Otito Iwuchukwu
  • Rachel Elsey
  • Raymond Lorenz
  • Simran Maggo
  • Thu Chan

Click here to view

Contact

  • Brian Serumaga, Director, Healthcare Quality and Safety Standards BNS@USP.org
  • Presha Regmi, Expert Committee Manager, Healthcare Quality & Safety Presha.Regmi@USP.org
  • Farah Towfic, Senior Director, Healthcare Quality & Safety Center of Excellence Farah.Towfic@USP.org
small molecules

Small Molecules

Focus Areas

  • Antibiotic, antiviral, and antimicrobial drug substance and drug product monographs
  • Selected general chapters that pertain to antibiotic, antimicrobial, and antiviral monographs

Expert Committee Charge

The Small Molecules Therapeutic Areas 1 (SM1) Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the following therapeutic categories: antibiotics, antimicrobials and antivirals

Key Goals

  • Conversion of microbial assays to HPLC assays
  • Work with other Small Molecules Therapeutic Areas Expert Committees, FDA, and stakeholders to discuss and address issues that are related to the standard setting of USP monographs

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Standard Setting Subcommittee (Reference Materials)

Standards Development 

  • The latest ballot results can be found at here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here. 

Learn more about the impact of this EC and its Associated Expert Bodies 

Roster

  • Mary Seibel (Chair)
  • Andre Hermans
  • Antony Raj Gomas
  • Deborah Havlik
  • Gennady Ananchenko
  • George Wall
  • Greg Kaster
  • Jeffrey Rohrer
  • Kaushik Panigrahi
  • Mahalakshmi Vasan
  • Monika Jain
  • Reinhard Walter
  • Sheila Deneau

Click here to view

Contact 

Small Molecules Therapeutic Areas 1

Small Molecules Therapeutic Areas 1

Focus Areas

  • Antibiotic, antiviral, and antimicrobial drug substance and drug product monographs
  • Selected general chapters that pertain to antibiotic, antimicrobial, and antiviral monographs

Expert Committee Charge

The Small Molecules Therapeutic Areas 1 (SM1) Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the following therapeutic categories: antibiotics, antimicrobials and antivirals

Key Goals

  • Conversion of microbial assays to HPLC assays
  • Work with other Small Molecules Therapeutic Areas Expert Committees, FDA, and stakeholders to discuss and address issues that are related to the standard setting of USP monographs

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Standard Setting Subcommittee (Reference Materials)

Standards Development 

  • The latest ballot results can be found at here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here. 

Learn more about the impact of this EC and its Associated Expert Bodies 

Roster

  • Mary Seibel (Chair)
  • Andre Hermans
  • Antony Raj Gomas
  • Deborah Havlik
  • Gennady Ananchenko
  • George Wall
  • Greg Kaster
  • Jeffrey Rohrer
  • Kaushik Panigrahi
  • Mahalakshmi Vasan
  • Monika Jain
  • Reinhard Walter
  • Sheila Deneau

Click here to view

Contact 

Focus Areas 

  • Cough, cold and analgesic drug substance and drug products monographs 

Expert Committee Charge 

The Small Molecules Therapeutic Areas 2 (SM2) Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the areas of cough, cold, and analgesic drug substance and drug product monographs. 

Key Goals 

  • Work with other Small Molecules Therapeutic Areas Expert Committees, FDA and stakeholders
  • Development of a Flexible approach to OTC monographs methods 

Subgroups and Expert Panels 

  • Small Molecules Collaborative Group
  • Joint Standard Setting Subcommittee (Reference Materials) 

Standards Development 

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here. 

Learn more about the impact of this EC and its Associated Expert Bodies 

Roster

  • Robert Buice (Chair)
  • Bo Wang
  • Christine Pettit
  • Donna Seibert
  • Fangming Lin
  • Hamid Rezaei
  • Jonathan Zeszotarski
  • Kylen Whitaker
  • Manish Gangrade
  • Maria Ines R.M.Santoro
  • Michael Wisser
  • Patrick Yat
  • Scott Roberts
  • Zhenyu Wang

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Contact 

Small Molecules Therapeutic Areas 2

Small Molecules Therapeutic Areas 2

Focus Areas 

  • Cough, cold and analgesic drug substance and drug products monographs 

Expert Committee Charge 

The Small Molecules Therapeutic Areas 2 (SM2) Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the areas of cough, cold, and analgesic drug substance and drug product monographs. 

Key Goals 

  • Work with other Small Molecules Therapeutic Areas Expert Committees, FDA and stakeholders
  • Development of a Flexible approach to OTC monographs methods 

Subgroups and Expert Panels 

  • Small Molecules Collaborative Group
  • Joint Standard Setting Subcommittee (Reference Materials) 

Standards Development 

  • The latest ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here. 

Learn more about the impact of this EC and its Associated Expert Bodies 

Roster

  • Robert Buice (Chair)
  • Bo Wang
  • Christine Pettit
  • Donna Seibert
  • Fangming Lin
  • Hamid Rezaei
  • Jonathan Zeszotarski
  • Kylen Whitaker
  • Manish Gangrade
  • Maria Ines R.M.Santoro
  • Michael Wisser
  • Patrick Yat
  • Scott Roberts
  • Zhenyu Wang

Click here to view

Contact 

Focus Areas

Gastrointestinal, renal, endocrine, and oncology and drug product monographs

Expert Committee Charge

The Small Molecules Therapeutic Areas 3 (SM3) Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in the areas of gastrointestinal, renal, endocrine, and oncology drug substance and drug product monographs.

Key Issues

  • Work with other Small Molecules therapeutic Areas Expert Committees, FDA, and stakeholders Subgroups and Expert Panels

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Subcommittee (Reference Materials)

Standards Development

  • The latest ballot results can be found at here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Eric Kesslen (Chair)
  • Bianca Avramovitch
  • Debashis Das
  • Gregory Webster
  • John Baker
  • Joseph Stowell
  • Mei-Chih Lin
  • Mijeong Kim
  • Murugan Saravanan
  • Radhika Rajagopalan
  • Rick Cesati
  • Samuel Akapo
  • Willaine Costa Pagliarini
  • Yuri Goldberg

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Contact

Small Molecules Therapeutic Areas 3

Small Molecules Therapeutic Areas 3

Focus Areas

Gastrointestinal, renal, endocrine, and oncology and drug product monographs

Expert Committee Charge

The Small Molecules Therapeutic Areas 3 (SM3) Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in the areas of gastrointestinal, renal, endocrine, and oncology drug substance and drug product monographs.

Key Issues

  • Work with other Small Molecules therapeutic Areas Expert Committees, FDA, and stakeholders Subgroups and Expert Panels

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Subcommittee (Reference Materials)

Standards Development

  • The latest ballot results can be found at here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Eric Kesslen (Chair)
  • Bianca Avramovitch
  • Debashis Das
  • Gregory Webster
  • John Baker
  • Joseph Stowell
  • Mei-Chih Lin
  • Mijeong Kim
  • Murugan Saravanan
  • Radhika Rajagopalan
  • Rick Cesati
  • Samuel Akapo
  • Willaine Costa Pagliarini
  • Yuri Goldberg

Click here to view

Contact

Focus Areas

  • Psychiatric, psychoactive, neuromuscular, radiopharmaceuticals, and imaging drug substance and drug product monographs
  • Selected general chapters that pertain to radiopharmaceuticals

Expert Committee Charge

  • The Small Molecules 4 Therapeutic Areas (SM4) Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in the areas of psychiatric, psychoactive, neuromuscular, radiopharmaceutical, and imaging drug substance and drug product monographs.
  • The SM4 Expert Committee is also responsible for supporting the development of general chapters related to radiopharmaceutical and imaging drug substances and drug products.

Key Goals

  • Work with other Small Molecules Therapeutic Areas, General Chapters, and FDA and stakeholders to discuss and address issues are related to standards setting
  • Support important global health issues through collaboration with other organizations

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Standard Setting Subcommittee (Reference Materials)

Standards Development

  • The latest ballot results can be found at here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Partha Mukherjee (Chair)
  • Alphard Orot
  • David Elder
  • James Salas
  • Josep M. de Ciurana Gay
  • Kathleen Brady
  • Mariann Neverovitch
  • Martin Williamson
  • Min Xia
  • Mohamed Ali
  • Romain Bejot
  • Shawn Dressman
  • Trevor Williams

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Contact

Small Molecules Therapeutic Areas 4

Small Molecules Therapeutic Areas 4

Focus Areas

  • Psychiatric, psychoactive, neuromuscular, radiopharmaceuticals, and imaging drug substance and drug product monographs
  • Selected general chapters that pertain to radiopharmaceuticals

Expert Committee Charge

  • The Small Molecules 4 Therapeutic Areas (SM4) Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in the areas of psychiatric, psychoactive, neuromuscular, radiopharmaceutical, and imaging drug substance and drug product monographs.
  • The SM4 Expert Committee is also responsible for supporting the development of general chapters related to radiopharmaceutical and imaging drug substances and drug products.

Key Goals

  • Work with other Small Molecules Therapeutic Areas, General Chapters, and FDA and stakeholders to discuss and address issues are related to standards setting
  • Support important global health issues through collaboration with other organizations

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Standard Setting Subcommittee (Reference Materials)

Standards Development

  • The latest ballot results can be found at here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Partha Mukherjee (Chair)
  • Alphard Orot
  • David Elder
  • James Salas
  • Josep M. de Ciurana Gay
  • Kathleen Brady
  • Mariann Neverovitch
  • Martin Williamson
  • Min Xia
  • Mohamed Ali
  • Romain Bejot
  • Shawn Dressman
  • Trevor Williams

Click here to view

Contact

Focus Areas

  • Pulmonary, Aerosol, Inhalation and Steroid drug substance and drug product monographs
  • Selected general chapters that pertain to General Chapters <351> Assay for Steroids and <511> Single-Steroid Assay

Expert Committee Charge

  • The Small Molecules 5 (SM5) Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the areas of pulmonary, aerosol, inhalation, and steroid drug substance and drug products.
  • The SM5 Expert Committee is also responsible for supporting the development of new general chapters related to pulmonary and steroids drug substances and drug products.

Key Goals

  • Work with other Small Molecules, General Chapters, and OTC Expert Committees, FDA and stakeholders to discuss and address issues related to standards setting

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Standard Setting Subcommittee (Reference Materials)

Standards Development

  • The latest ballot results can be found at here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Justin Pennington (Chair)
  • D.J. Doan
  • Gurvinder Singh Rekhi
  • Hwei-Fang Cheng
  • Jigar Mehta
  • Jonathan Parks
  • Maria Lurantos
  • Oscar Liu
  • Pavel Parkhomyuk
  • Tim Gibson
  • Tyrone Spiva
  • Xiaobin Shen

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Contact

Small Molecules Therapeutic Areas 5

Small Molecules Therapeutic Areas 5

Focus Areas

  • Pulmonary, Aerosol, Inhalation and Steroid drug substance and drug product monographs
  • Selected general chapters that pertain to General Chapters <351> Assay for Steroids and <511> Single-Steroid Assay

Expert Committee Charge

  • The Small Molecules 5 (SM5) Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the areas of pulmonary, aerosol, inhalation, and steroid drug substance and drug products.
  • The SM5 Expert Committee is also responsible for supporting the development of new general chapters related to pulmonary and steroids drug substances and drug products.

Key Goals

  • Work with other Small Molecules, General Chapters, and OTC Expert Committees, FDA and stakeholders to discuss and address issues related to standards setting

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Standard Setting Subcommittee (Reference Materials)

Standards Development

  • The latest ballot results can be found at here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Justin Pennington (Chair)
  • D.J. Doan
  • Gurvinder Singh Rekhi
  • Hwei-Fang Cheng
  • Jigar Mehta
  • Jonathan Parks
  • Maria Lurantos
  • Oscar Liu
  • Pavel Parkhomyuk
  • Tim Gibson
  • Tyrone Spiva
  • Xiaobin Shen

Click here to view

Contact

Focus Areas

Cardiovascular, Ophthalmology, Otic, Dermatology, and Veterinary drug substance and drug product monographs

Expert Committee Charge

The Small Molecules 6 Therapeutic Areas (SM6) Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in the areas of cardiovascular, ophthalmology, otic, dermatology, and veterinary drug substances and drug products.

Key Goals

  • Work with other Small Molecules Therapeutic Areas Expert Committees, FDA, and stakeholders to discuss and address issues that are related to the standard setting of USP monographs

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Standard Setting Subcommittee (Reference Materials)

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Allan Bokser (Chair)
  • Andrew Bluj
  • Beth Minter
  • Dev Singh
  • Heewon Lee
  • Jasmina Novakovic
  • Jeff Schwartzenhauer
  • Jose Zayas
  • Luciano Virgili
  • Mantena Bhaskara Praveen Varma
  • Mark Papich
  • Philip Floyd
  • Shane Gassman

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Contact

Small Molecule Therapeutic Areas 6

Small Molecule Therapeutic Areas 6

Focus Areas

Cardiovascular, Ophthalmology, Otic, Dermatology, and Veterinary drug substance and drug product monographs

Expert Committee Charge

The Small Molecules 6 Therapeutic Areas (SM6) Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in the areas of cardiovascular, ophthalmology, otic, dermatology, and veterinary drug substances and drug products.

Key Goals

  • Work with other Small Molecules Therapeutic Areas Expert Committees, FDA, and stakeholders to discuss and address issues that are related to the standard setting of USP monographs

Subgroups and Expert Panels

  • Small Molecules Collaborative Group
  • Joint Standard Setting Subcommittee (Reference Materials)

Learn more about the impact of this EC and its Associated Expert Bodies

Roster

  • Allan Bokser (Chair)
  • Andrew Bluj
  • Beth Minter
  • Dev Singh
  • Heewon Lee
  • Jasmina Novakovic
  • Jeff Schwartzenhauer
  • Jose Zayas
  • Luciano Virgili
  • Mantena Bhaskara Praveen Varma
  • Mark Papich
  • Philip Floyd
  • Shane Gassman

Click here to view

Contact