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

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

Congratulations to all!!

• The Stability Focus Group has a planned face-to-face meeting at the 2008 AAPS National Convention in Atlanta, Georgia – tentatively scheduled for Wednesday November 19, 2008 12 noon- 1pm. This is a great opportunity to come, join the group, meet other group members, network with your colleagues, enlist new members, obtain information from your leadership team and discuss stability issues. Please mark your calendar! See the final meeting brochure for details.
• There are also two Stability related sessions that may be of interest:
  • "Current Drug Product Stability Issues", symposium, to be held on Monday, Oct 30, from 2pm-4:30pm, in room 217C, Convention Center.
  • "Stability Fundamentals of API and Drug Product", sunrise school, to be held on Thursday, November 2, from 7am-8:30am in Ballroom C-2, Convention Center.
  • For more information, please go to www.aapspharmaceutica.com/annualmeeting. We hope to see you there!
• AAPS Webinar Series are available free of charge to the public. Upcoming webinars:
  • "Dissolution Method Development", October 2nd, given by Dr. Erika Stippler, USP.
  • "Accelerated Stability Assessment Program: Using Science to Set Shelf-Life", given by Dr. Ken Waterman, Pfizer. Date is to be determined.
• The AAPS SFG is taking nominations for new SFG Steering Committee Members.

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.

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

Stability-Related Links and Guidance

The latest revision of the WHO Stability Guideline (rev. 3) has been released for comments. This revision is based on comments received and reviewed during an informal consultation to discuss stability studies in a global environment which was held in the WHO Eastern Mediterranean Regional Office (EMRO) in Cairo on 19-21 August 2008. The WHO Expert Committee on Specifications for Pharmaceutical Preparations had agreed in October 2006 in general to prepare this working document as a draft that could serve as a replacement for the WHO guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms, which were published in 1996, and to include a list of long-term stability conditions as required by WHO Member States.

More information can be found on stability-related issues at the following website: http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html

The CHPA (Consumer Healthcare Products Association) Stability Working Group has published the following voluntary OTC stability guidelines which will be of discussion at an upcoming October 7, 2008 CHPA MCS Stability Workshop. More information is available at www.chpa-info.org

• CHPA Voluntary OTC Stability Guideline- Changes to Products 10-05-07 (PDF)
• Q1A Rewrite for OTC Final Draft - Industry Comments Incorporated 8-9-04 (PDF)

JOIN THE STABILITY FOCUS GROUP

To join the Stability Focus Group, click here.

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