• Section Affiliations
  • Analysis and Pharmaceutical Quality (APQ)
  • Regulatory Sciences (RS)

• Fall 2009 Stability Workshop: The AAPS Stability Focus Group has developed a Stability Workshop for Fall 2009 that will address the role of stability in today’s increasingly complex pharmaceutical development process and ongoing manufacturing environment. This workshop will bring together scientists and regulators from around the world to discuss current requirements, and best practices to address these challenges. Details to follow once dates/venue confirmed.
• AAPS Webinar Series–Upcoming webinar: "Validating Analytical Methods Based on Current ICH Guidance and USP/Industry Standards" Friday, February 20, 2009 12:30 PM - 2:00 PM EST (More info)

At the stability testing workshop held November 2005 at the AAPS Annual Meeting and Exposition in Nashville, TN, discussions were initiated about forming a focus group to discuss the issues with stability testing and interpretation of new regulatory guidances. Ideally and globally, we are striving for an understanding, discussion and solutions to several issues relating to stability testing of API and finished products. Stability testing is the backbone of drug development and approval, the product will not be approved without adequate stability information. Issues related to stability profile of the API or formulated product normally delay product development as well as regulatory submission.

The goals of this focus group are to:

1. establish a core group of interested scientists to explore diverse areas of stability sciences;
2. define technical issues related to stability filing requirements in different climatic zones;
3. provide a forum to discuss stability scientific issues and exchange best practices;
4. organize quality programs for the annual meeting and to conduct workshops on current ICH/FDA and international requirements;
5. provide an avenue for training of new guidances on stability related topics; and
6. act as a link among members of industry, academy and regulatory.

• June 2009

AAPS Stability Focus Group Survey Results: Input on the Current Practices within the Pharmaceutical and Biopharmaceutical Industry

Stability-Related Links and Guidance

Voluntary Stability Guidelines—CHPA's Stability Working Group, a subcommittee of the Manufacturing Controls Committee, is currently active in finalizing the voluntary stability guidelines published on CHPA's members-only Science & Technology Issues home page. The team is working to incorporate the comments presented at CHPA's fall Manufacturing Controls Seminar by FDA's Scott Furness. Furthermore, the team has begun discussions of creating an impurities guideline for industry. If your company would like a representative on the Stability Working Group, please contact CHPA's Rachael Roehrig.

JOIN THE STABILITY FOCUS GROUP

To join the Stability Focus Group, click here.

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Stability Focus Group Past Chair, Kim Huynh-Ba, received
the APQ Service Award from 2008 APQ Chair, Vivian Gray

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