Pharmaceutical Water & Steam Systems

Module Lenght

from 1 day and a half to 2 days

Agenda

  • Regulatory aspect from International Agencies
  • Technical Background from cGEP (Good Engineering Procedures)
  • Pure Steam
  • Validation Life Cycle
    • Design Qualification
    • Installation Qualification
    • Operational Qualification
    • Calibration
    • Performance Qualification
  • Microbial considerations
  • Industry perspective and Regulatory challenges
  • Inspection
  • Operational and Maintenance Aspects

Target audience

  • Manufacturing
  • Quality Assurance
  • Quality Control
  • Validation
  • Engineering
  • Maintenance

Learning tools

  • Presentations
  • Lectures
  • Case Studies
  • Discussion
  • Question & Answers session

Regulatory & technical references

  • EP Water Monographs & Tests
  • USP Water Monographs
  • JP – Japanese Pharmacopoeia
  • FB – Farmacopéia Brasileira: Agua para uso farmaceutico, Agua monographs
  • WHO TRS 970 Annex 2 “Water for Pharmaceutical Use (WPU)”
  • PIC/S PI 009-3 “PIC/S) Aide Memoire: Inspection of Utilities”
  • ISPE – Baseline Vol. 4 “Water and Steam Systems”ISPE – Good Practice Guide “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems “
  • ISPE – Good Practice Guide “Ozone Sanitization of Pharmaceutical Water Systems “
  • EMA – CPMP/QWP/158/01 “Note for Guidance on Pharmaceutical Water Quality to Inspection of High Purity Water Systems”
  • FDA “Guide to Inspection of High Purity Water Systems”
  • ANVISA (Brasil) – Guia de Qualidade para Sistemas de Purificação de Água para Uso Farmacêutico
  • ASME BPE 2014 Bioprocessing Equipment
  • EDQM “EDQM Expert Workshop – Water For Injections – Potential Use Of Membrane Systems For The Production”
  • EMEA “Reflection Paper on Water for Injection Prepared by Reverse Osmosis”
  • CFPP 01-01C “Choice Framework for local Policy and Procedures 01-01 – Management and decontamination of surgical instruments (medical devices) used in acute care. Part C: Steam sterilization”

Number of trainers

One

Tailoring option available

Yes

Final evaluation quiz

Yes

Contact

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