ISPE Updates Guide to include Key Concepts of a Global Implementation
Pharmaceutical water and clean (pure) steam are used as utilities and ingredients for Good Manufacturing Practice (GMP) processes, which produce drug products and drug substances such as Active Pharmaceutical Ingredients (APIs). In addition, water may be used as a final product, such as USP packaged waters.
Commissioning and qualification brings the water or steam system into operation, through the design and construction project phases and verifies that these GMP systems (equipment and controls) create product (water and steam) with a consistent and repeatable quality. Qualification also verifies that supporting quality systems have been integrated into the validation life cycle to\ maintain the validated state.
The ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems provides a complementary approach on how commissioning and qualification correspond and relate to the validation life cycle risk management, PAT and QbD. In addition, the Guide aims to provide alternative approaches for the validation of water and steam systems that undergo commissioning and qualification. Key concepts and principles addressed in the revision include the validation life cycle, critical components, non-critical components, and impact assessment.
Ultimately, the goal is to increase understanding of GMP water and steam systems in the pharmaceutical and biotechnology industries. Although there are a number of ways of achieving this goal, ISPE’s Guide describes one example of how to implement a science and risk-based approach.
Discussion is centered on those items which directly affect water or steam quality attributes during production, storage, and distribution.
For a preview of the Guide, download Appendix 1, which features a typical WFI generation and distribution system component classification example.