Generic Industry’s Perspective on the New GMP

Initiative2002

Generic Pharmaceutical Association

Kenneth Lavin, M.Sc. Director, Regulatory Compliance

TEVA Pharmaceuticals USA

Modernization and Consistent Enforcement of cGMPs is Needed:

• Center and Field

• District to District

•Best Approach: Guidance Documents Needed

• Examples:

– Cleaning Validation– Process Validation– Training– Vendor Qualification

Cleaning Validation

• Levels

• Matrix Approach

• Monitoring Program

Process Validation

• Impact of Validation in Future Production

• Lessen requirements for commercial production.

• Unnecessary Testing.

Training

• Level

• Documentation / Tracking

Vendor Qualification

• Repeat of testing

• Reduced Testing

• Documentation / Rational

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.