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