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

Contact

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