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Generic Industry’s Perspective on the New GMP Initiative 2002 Generic Pharmaceutical Association Kenneth Lavin, M.Sc. Director, Regulatory Compliance TEVA.

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Presentation on theme: "Generic Industry’s Perspective on the New GMP Initiative 2002 Generic Pharmaceutical Association Kenneth Lavin, M.Sc. Director, Regulatory Compliance TEVA."— Presentation transcript:

1 Generic Industry’s Perspective on the New GMP Initiative 2002 Generic Pharmaceutical Association Kenneth Lavin, M.Sc. Director, Regulatory Compliance TEVA Pharmaceuticals USA

2 Modernization and Consistent Enforcement of cGMPs is Needed: Center and Field District to District

3 Best Approach: Guidance Documents Needed Examples: –Cleaning Validation –Process Validation –Training –Vendor Qualification

4 Cleaning Validation Levels Matrix Approach Monitoring Program

5 Process Validation Impact of Validation in Future Production Lessen requirements for commercial production. Unnecessary Testing.

6 Training Level Documentation / Tracking

7 Vendor Qualification Repeat of testing Reduced Testing Documentation / Rational

8 Summary – Guidance GPhA welcomes the opportunity to work with FDA, industry and academia on developing the science to create the procedure to allow for a new regulatory framework.


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