Implementation Of Ichq8 Q9 & Q10 Guidelines

Implementation of ICH Q8, Q9, and Q10 Guidelines

FDA/Industry Panel Discussion 2006 GPHA Fall Technical Conference Nicholas Cappuccino, Ph.D. Andrx Pharmaceuticals

Agenda n n n n

The ICH process History and status of the Guidelines Nuts and bolts of the Guidelines Status in US Drug Regulation

The ICH Process n n n n n

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A ‘harmonization’ Process 3 Regions: US, EU, and Japan Six Parties 5 step Guideline Process ICH Q8, Q9, Q10 and FDA’s Pharmaceutical CGMPs for the 21st Century Q8, Q9, and Q10 are different from other ICH guidelines in that they are more philosophical than procedural

ICH Q8 Pharmaceutical Development n n

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Accepted as an ICH topic in September 2003 Provides guidance on Section 3.2.P.2 of the Common Technical Document Reached Step 5 in November 2005 Published in Federal Register Volume 71, No. 98 on May 22, 2006 Introduced concept of “design space” and “regulatory flexibility” for post-approval changes Question-Based Review Initiative by OGD Q8(R1) under development by ICH EWG

ICH Q9 Quality Risk Management n n

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Accepted as an ICH topic in September 2003 Provides principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality Reached Step 5 at ICH in November 2005 Published in Federal Register Volume 71, No. 106 on June 2, 2006 Q9 Briefing Pack available at ICH website, www.ich.org

ICH Q10 Pharmaceutical Quality Systems n

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Formally accepted as an ICH topic in September 2005 after 2 years of “informal” discussions among quality experts at formal ICH meetings Focus is to complement and facilitate the implementation of Q8 and Q9 and a bridge among different regional regulations ICH Step 1 document under discussion at ICH meeting in Chicago next week Projected to reach ICH Step 2 in spring/summer 2007 FDA September 2006 Guidance: Quality Systems Approach to Pharmaceutical CGMP Regulations