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.