Primary Packaging Qualification
Module Lenght
1 day
Agenda
- International Regulatory Context
- Requirements (USP, EPh, ISO and ICH regulations)
- Qualification Risk Assessment
- Material Qualification
- Process Material in contact with the drug formulation
- Primary, Secondary and Tertiary Container Packaging
- Validation Matrix Development
- Toxicological Assessment
- Practical Case Studies
- Container Closure Integrity (CCI)
- Container Closure Test Methodology
- Development and Validation of Integrity Test Methods
- Testing Requirement definition
- Testing Strategy Development
- Method Validation Strategy
- Practical Case Study
- Practical Workshop (Optional)
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
- Workshops
-
Regulatory & technical references
- EU GMP Annex 1
- I.C.H. Q8 Pharmaceutical Development
- USP <1207> Container Closure Integrity Testing
- USP <660> Containers – Glass
- USP <661> Containers – Plastics
- USP <381> Elastomer Closures for Injections
- USP <1660> Evaluation of the Inner Surface Durability of Glass Containers
- USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
- USP <1664> Assessment of Leachables Associated with Pharmaceutical Packaging/Delivery Systems
- PDA TR 27 Pharmaceutical Packing Integrity
Number of trainers
One/Two
Tailoring option available
Yes
Final evaluation quiz
Yes