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

• Publication by Springer (publisher) on our Proceedings Book from our 1st Stability Workshop held in Bethesda MD in September 2007, "Pharmaceutical Stability Testing to Support Global Markets" has been completed. A total of 30 articles have been included in this book. Also, the following stability-related book is also available from Springer: "Handbook of Stability Testing in Pharmaceutical Development", Kim Huynh-Ba (ed.)
• 2010 AAPS Webinar Series – Upcoming Webinars
• Call for volunteers to serve on the AAPS Stability Focus Group Steering Committee –send name(s) to Focus Group Chair - Dilip Choudhury.
• Call for nomination of 2012-2014 SFG Chairperson - send name(s) to Focus Group Chair - Dilip Choudhury and Abbie Gentry.

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

• APQ/RS Global Outreach Program on Pharmaceutical Stability, March 2010
• AAPS Stability Focus Group Survey Results: Input on the Current Practices within the Pharmaceutical and Biopharmaceutical Industry

Stability-Related Links and Guidance

• World Health organization (WHO):
  • The WHO has issued its final guideline "Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products", WHO Technical Report Series, No. 953, 2009. http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
• FDA
  Newly added guidance documents:
  1. Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
     • Annex 5: Disintegration Test General Chapter
     • Annex 8: Sterility Test General Chapter
  2. International Conference on Harmonisation - Quality (Final, 12/22/2009)
  
  Genotoxic and carcinogenic properties can be acceptable traits of active pharmaceutical ingredients (APIs) but when these are impurities, which generally do not have a beneficial effect, their presence should be minimised. To help manufacturers achieve the lowest technically feasible levels of these impurities, or reduce them to quantities that convey no significant cancer risk, the US Food and Drug Administration (FDA) has issued guidance on the subject.
  1. "Guidance for Industry: Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches" December 2008, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065014.htm
  2. "ANDAs: Impurities in Drug Substances (Generics)", July 2009. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

JOIN THE STABILITY FOCUS GROUP

To join the Stability Focus Group, click here.

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