Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables

Extractables & Leachables
December 9, 2013 - December 10, 2013

Overview

Co-sponsored by: : 
USP and PQRI
Overview: 

Plastic packaging systems for pharmaceutical products should adequately protect the product, be compatible with the product, and be composed of materials that are safe for use. From a chemical perspective, ingredients from a pharmaceutical product should not be absorbed onto the surface or into the body of the plastic packaging system. Furthermore, the packaging system should not release substances that can accumulate in the pharmaceutical product in quantities sufficient to affect its stability or to present a risk of toxicity.

To this end, USP is proposing the revision and development of a suite of plastic packaging system standards that recently published in Pharmacopeial Forum 39 (5) (September 2013). The PQRI Extractables and Leachable Working Group is also working to develop guidelines, specifically for packaging systems used for parenterals and ophthalmic drug products. The purpose of this workshop is to bring stakeholders together to discuss and collect feedback on the new standards and recommendations by both organizations.

Objectives: 

The purpose of the Extractables and Leachables Workshop is to present, discuss, and get stakeholders’ feedback on new extractables and leachables standards and recommendations:

  1. USP
    1. <661> Plastic Packaging Systems and their Materials of Construction
      1. <661.1> Plastic Materials of Construction
      2. <661.2> Plastic Packaging Systems for Pharmaceutical Use
    2. <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
    3. <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
      1. <1664.1> Orally Inhaled and Nasal Drug Products
  1. PQRI
    1. Safety Thresholds and Best Practices for Extractables and Leachables in Parenterals and Ophthalmic Drug Products
Who Should Participate: 

This workshop is intended for all stakeholders (industry, regulators, and associations) interested in characterizing and measuring these molecules in biotechnology products.

Professionals working in or with pharmaceutical packaging and delivery systems, including:

  • Research and development
  • Contract research organizations
  • Contract manufacturing organizations
  • Regulatory affairs
  • Quality assurance/quality control

For additional information, email us at conferences@usp.org or call +1-301-816-8130.

Additional Resources

Agenda

Registration Information

Regular Price Information: 
  • Industry—$895
  • AAG—$695
  • Government—$100
    Student (must present valid student ID)—$150

Combined Pricing (Short Course + Workshop)

  • Industry/Academia/Association—$1,020 
  • Government/Student—$595
Group Discount Information: 

Three or more attendees from the same company:

  • Industry—$595 per person
  • AAG—$495 per person
Other Registration Information: 
  • Short Course Only—$745

Registration fee includes full two-day program, meeting materials, continental breakfast and lunch each day, and a networking reception. Contact conferences@usp.org for details.

12601 Twinbrook Parkway
Rockville, MD 20878
United States
Phone: +1-301-816-8130
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