September 22, 2011

CONVENTION

Convention Member Organizations Urged to Appoint Delegates—Deadline Approaching—Reminder letters were sent to all Convention member organizations that have not appointed delegates since invitations were mailed in November 2010.  Of 472 Convention members, 322 have named delegates.  The USP Bylaws allow removal of a member organization for failure to name a delegate for a 12-month period, or failure of a Delegate to attend two consecutive Regular Membership Meetings. Delegate appointments may be made by sending the name and contact information (including email address) to membership@usp.org or by completing the Appointment Form on the Member Web page.

HEADQUARTERS

Register for November USP Workshop on Adulteration of Food Ingredients and Dietary Supplements—Professionals who work in food or dietary supplement research and development, formulation, manufacturing, compliance, regulatory affairs, validation, or QA/QC are encouraged to attend the USP Workshop on Intentional and Unintentional Adulteration of Food Ingredients and Dietary Supplements, scheduled for November 16–17, 2011 at USP Headquarters in Rockville, MD.  Dr. Jonathan DeVries, senior technical manager of Medallion Industries, General Mills, who serves as chair of USP's Food Ingredients Intentional Adulterants Expert Panel, discusses the issue of economically motivated adulteration of food ingredients in a recent video on the Food Navigator-USA web site.

FDA Co-Sponsors OTC Workshop September 8-9; Janet Woodcock Interviewed—USP and FDA jointly sponsored an important Over-the-Counter (OTC) Drug Substances and Drug Products Workshop on September 8-9, 2011.  Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at FDA and Dr. Roger Williams, USP’s Chief Executive Officer pledged to work together to ensure the quality of OTC medicines and welcomed industry’s input on how to identify and fill the current gaps that exist.  Mr. Scott Melville, CEO of the OTC industry’s Consumer Healthcare Products Association addressed the need to underpin efforts with sound science.  The workshop set the stage for continued collaboration toward improved standards to protect patients and consumers.  View a special interview with Dr. Woodcock on the importance of the modernization initiative.

Register for October Science & Standards Symposium on Biologics & Biotechnology—Only a few days remain for biologics and biotechnology professionals, regulators, and researchers to register for USP’s 2011 Science & Standards Symposium set for October 3-6, 2011 in Seattle, WA.  Participants will have an opportunity to interact with a panel of international experts on topics related to biologics and biotechnology analytics and assays, including the regulatory landscape and the role of USP standards.

Read About Fetal Bovine Serum, Other Topics in Latest Issue of The Standard—Fetal bovine serum (FBS) is used as a cell culture growth supplement in the manufacture of certain biotechnology products.  It is rich in key ingredients that support cell prolifieration and has low antibody levels, lessening the likelihood of a triggered interaction between the serum and other cellular materials.  In May 2011, the new documentary standard, General Chapter <90> Fetal Bovine Serum – Quality Attributes, became official in USP-NF.  This chapter provides test methods to measure the quality of fetal bovine sera across the industry. The Standard also covers: USP's new ventures into international philanthropy; Technical Assistance Program training in Ghana; announcement of the Medicines Compendium; a Q&A with Dr. Tina Morris on the upcoming biologics Science and Standards Symposium; USP's suite of chapters on compounding, demonstrating our ongoing commitment to practitioners; new proposed standards in FCC;interviews with the first group of visiting scientists; the opening of PQM's first permanent overseas office in Ethiopia; and more.

Receive Free Information on B&B, Monograph Modernization, and More—Receive free information about the latest products and services from USP by subscribing to an e-Newsletter.  Topics include:

  • Food Chemicals Codex
  • Dietary Supplements
  • Biologics & Biotechnology (B&B)
  • Excipients
  • Monograph Modernization
  • Compendial Updates
  • Pharmacopeial Education
  • Compendial Updates

INTERNATIONAL

USP Opens New Lab, Office Facility in India—On September 2, 2011, USP marked the opening of a new, larger site in Hyderabad, India with a special ceremony.  The site expansion (now 100,000 square feet from a previous 14,000) will support USP’s current collaborative testing, pharmacopeial education, verification, and standards development and allow for future work in synthetic chemistry and bioanalytical chemistry and testing.  USP-India also supports USP’s Medicines Compendia, which seeks to address gaps in quality standards for medicines distributed around the world.  USP has enjoyed productive relationships with the Indian government and industry and looks forward to strong collaborations in the future in its new facility.

Visiting Scientists and USP Staff Exchange Knowledge, Develop Standards—Through USP’s Visiting Scientists Program, scientists from around the world contribute to the development of USP standards by working for 12 to 24 weeks at USP Headquarters in Rockville, MD.  Participants are selected through a competitive process based on their education, experience, and expertise in USP standards setting areas.  Interviews with several of these professionals is featured in the current issue of The Standard.

  • Mariam M. Jamal Al-Saber (Jordan Food and Drug Administration, Jordan)
  • Emad H. Amine Aly, Ph.D. (National Organization for Drug Control and Research [NODCAR], Egypt     
  • Elisabete Barbosa Antunes, M.Sc. (University of Sao Paulo, Brazil)
  • Maryna Dmitriieva, Ph.D. (Ukranian Scientific Pharmacopoeial Centre for Quality of Medicines [Ukraine Pharmacopoeia], Ukraine)
  • Kateryna O. Khokhlova (National University of Pharmacy, Ukraine)
  • Thi Minh Hue Khong, M.Sc. (National Institute of Drug Quality Control, Vietnam)
  • Rodolfo Malpartida (Pil Andina, S.A., Bolivia)
  • Cheetham L. Mingle, M.Sc. (Food and Drugs Board, Ghana)
  • Juliano Ferreira Silva, Ph.D (University of Sao Paulo, Brazil)