Pharmaceutical Water Systems: Part 2 - Design, Operation & Qualification

About the Course

Water is one of the most critical utilities in pharmaceutical manufacturing, directly impacting product quality and patient safety. This comprehensive module, is designed to equip drug inspectors and auditors with a strong foundational understanding of pharmaceutical-grade water systems, focusing on both technical and regulatory perspectives. Learners will begin by exploring the principles and technologies behind the generation of Water for Injection (WFI), including distillation and alternative methods such as reverse osmosis and ultrafiltration. The module then covers key considerations in water storage and distribution, emphasizing design controls, material selection, and microbial risk mitigation.

A dedicated section on sanitization of water systems guides learners through validated thermal and chemical sanitization practices to ensure microbial control and system reliability. The final segment addresses the qualification of water systems, detailing the critical phases of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), along with lifecycle monitoring and review.

Content

• Water for injection
  • Water for injection and application
  • Basic distillation
  • WFI generation- Multi column distillation and vapor compression
  • WFI Specification
• Storage and Distribution System
  • Water Storage and Distribution: Key Considerations
  • Biofilms- formation and control
  • Typical Design of Water Distribution System
  • Endotoxins control & ultrafiltration
  • Automation and Controls Water Distribution System
• Sanitization of water systems
  • Purified & WFI Distribution System
  • Microbial control of water systems
  • Sanitization modes- Thermal, chemical sanitization
• Qualification of water systems
  • Qualification approach
  • Qualification of Water systems
  • Phases of PQ
  • Water Sampling

Summary and Conclusion: Life cycle management of Water Systems

Final Evaluation: 3 attempts to achieve the passing score in the evaluation.