Cleaning Validation

Module Lenght

1 day

Agenda

  • Cleaning Validation Concepts
    • International Regulatory Context
    • Maximum Allowable Limits of Carry Over (MACO)
    • Cleaning Validation Documents
  • Special Aspects of Cleaning Validation
    • Bracketing, worst case rating
      • Bracketing of products
      • Bracketing of equipment
    • Acceptance criteria
  • Cleaning Validation in
    • Biotech API Production Plants
    • Chemical API Production Plants
  • Technical and Organizational Aspects on Equipment Regarding Cleaning Procedures
    • Design and cleaning principle
    • Validation and maintenance for efficient cleaning
    • Case studies
  • Good practice to write a cleaning validation protocol
    • Current GMP Requirements
    • How to write a cleaning protocol
    • Summary
  • Practical Workshop (Optional)

Target audience

  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Technology Transfer
  • Validation
  • R&D
  • Manufacturing

Learning tools

  • Presentations
  • Lectures
  • Case Studies
  • Discussion
  • Question & Answers session
  • Final Evaluation Test
  • Workshops

Regulatory & technical references

  • MA/CHMP/SWP/169430/2012EMA Guideline on setting health based exposure limits for the use in risk identification in the manufacture of different medicinal products in shared facilities (EU GMP guideline Part III chapter 3.3.6)
  •  GMP Annex 15
  •  CFR 211.167 Equipment Cleaning and Maintenance
  • FDA Guide to Inspection Validation of Cleaning Processes
  • EU GMP guideline Part II Basic requirements for Active Substances used as starting materials
  • APIC: Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants, Mai 2014
  • PIC/S PI 006-3
  • I.C.H. Q3  Appendix 3 Impurities
  • “I.C.H. Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”
  • ISPE Vol 7: Risk based manufacture of pharmaceutical products
  • PDA TR 29 “Points to consider for Cleaning Validation”

Number of trainers

One/Two

Tailoring option available

No

Final evaluation quiz

Yes

Contact

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