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

10. Example Company Organizational Chart CEO Quality Compliance Manufacturing Quality Assurance Quality Control Clinical & Regulatory Affairs Regulatory Affairs

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Qa & Gmp 29 May2010

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