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

Contact

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