Extractables & Leachables

Module Lenght

1 day

Agenda

  • Extractables and Leachables
    • General Concepts
    • Importance of a good Extractables & Leachables qualification
  • International Regulatory Context
    • Requirements (EMEA, FDA and ICH)
  • Extractables and Leachables Strategy Approach
    • Conditions selection
    • Analytical Techniques and Methodologies
    • Leachable Study Design
  • Risk Assessment on Extractables and Leachables
  • Safety Evaluation
    • Toxicological Assessment
    • EMA guideline on Genotoxic Impurities
    • PQRI Threshold
  • Practical Case Studies on
    • Pre-filled Syringes
    • Lyophilized Drug Products
    • Injectables
    • Large Volume Parenterals
    • Disposable and Single-Use Systems
    • Single Use Equipment Process Validation Requirements

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

  • ICH Q7
  • FDA 21 CFR
  • USP <87>,<88>,<660>,<661>,<1660>, <1663>,<1664>
  • Eu cGMP Vol 4
  • PDA TR 26 “Sterilizing Filtration of Liquids”
  • PDA TR 66 ” Application of Single-Use Systems in Pharmaceutical Manufacturing”

Number of trainers

One/Two

Tailoring option available

Yes

Final evaluation quiz

Yes

Contact

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