Container Closure Integrity Testing
Module Lenght
1 day
Agenda
- International Regulatory Context
- USP <1207>, EPh, ICH
- PDA TR 27
- Container Closure Integrity Test Methodologies
- Classification
- Microbial and Physicochemical methods
- Limit of detection
- Development of Container Closure Integrity Testing Strategy
- Requirement definition
- Strategy Development
- Container Closure Integrity Testing Method Selection
- Selection guidance
- Selection consideration
- Development and Validation of Integrity Test Methods
- Best Practices
- Validation Strategy
- Case Studies
Target audience
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Technology Transfer
- Validation
- R&D
Learning tools
- Presentations
- Lectures
- Case Studies
- Discussion
- Question & Answers session
- Final Evaluation Test
Regulatory & technical references
- EU GMP Annex 1
- I.C.H. Q8 Pharmaceutical Development
- USP <1207> Container Closure Integrity Testing
- PDA TR 27 Pharmaceutical Packing Integrity
Number of trainers
One/Two
Tailoring option available
No
Final evaluation quiz
Yes