Generic Industry

1
Generic Industrys Perspective on the New GMP
Initiative

• 2002
• Generic Pharmaceutical Association
• Kenneth Lavin, M.Sc. Director, Regulatory
  ComplianceTEVA 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.