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

• Dr. Abbie Gentry – Chair
• Dr. Manuel Zahn – Chair Elect
• Dr. Dilip Choudhury – Vice Chair

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.

Stability Focus Group Meeting Minutes

Resources

Recent Developments on Long-Term Stability Test Conditions, The Pharma Review, December 2006

Stability Testing of Active Substances and Pharmaceutical Products Draft, World Health Organization, April 2006

Panama Stability Guidelines - November 2005

Draft Regional Stability Guideline for the WHO Eastern Mediterranean Region (EMR), version 2.0, April 2006

JOIN THE STABILITY FOCUS GROUP

To join the Stability Focus Group, click here.

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