Validation of pharmaceutical water, steam systems and process gases

Course Details

Module length 
From 1 DAY and a half to 2 Days 
Learning tools 
Presentations, Lectures, Case Studies, Discussion, Question & Answers session


Target audience 
Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Maintenance


Regulatory aspect from International Agencies (e.g. EMA/EDQM, USA-FDA/USP, ANVISA, ISPE, WHO)
Technical Background from cGEP (Good Engineering Procedures) (e.g. ASME BPE, ISPE Baseline)
New EP Monograph for WFI Production by Membrane Processes (April 2017): regulatory & technological challenges.
EU-Annex 1 revision contents
Validation Life Cycle
  • Design Qualification
  • Installation Qualification
  • Instruments Calibration
  • Operational Qualification
  • Performance Qualification
Pure Steam: Specific regulatory and Validation Aspects
Operational and Maintenance Aspects
Inspection points to consider from DOC experience
Case Studies from DOC experience

Regulatory & technical references

  • EU GMP Annex 1: “Manufacture of sterile medicinal products”
  • EP Water Monographs & Tests
  • USP Water Monographs
  • JP – Japanese Pharmacopoeia
  • FB – Farmacopéia Brasileira: Agua para uso farmaceutico, Agua monographs
  • WHO TRS1033 Annex 3 “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 2022 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”

Do you have any questions?