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Qa & Gmp 29 May2010

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Regulatory and QA Considerations for Drug Product Development Louise Johnson, M.S. Chinese American Biopharmaceutical Society Meeting June 5, 2010
Core Principles ,[object Object],[object Object],[object Object]
Topics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CMC Development Goals ,[object Object],[object Object],[object Object]
Standards Used to Ensure Product Quality ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Principles Underlying GMP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Affairs Function ,[object Object],[object Object],[object Object]
Quality Assurance Function ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Quality Control Function ,[object Object],[object Object],[object Object]
Example Company Organizational Chart CEO Quality Compliance Manufacturing Quality Assurance Quality Control Clinical & Regulatory Affairs Regulatory Affairs
So What CMC Information Is Needed At Each Stage Of Development? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CMC Information for Original IND ,[object Object],[object Object],[object Object],[object Object],[object Object]
IND for Phase 1 Study ,[object Object],[object Object],[object Object]
CMC Safety Concern Examples ,[object Object],[object Object],[object Object],[object Object]
IND – CMC Section ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
As Development Proceeds ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Examples of CMC Modifications That Can Affect Safety ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Phase 2 – CMC Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Phase 3 – CMC Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Phase 3 – CMC Information continued ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Advice for CMC Development ,[object Object],[object Object],[object Object],[object Object]
References for NDA Preparation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Thank you!

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Qa & Gmp 29 May2010

  • 1. Regulatory and QA Considerations for Drug Product Development Louise Johnson, M.S. Chinese American Biopharmaceutical Society Meeting June 5, 2010
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