E10 Critical Utilities - Purified Water System
In most GMP environments, Critical Utilities (including Purified Water System, WFI, Pure Steam) are critical components of the manufacturing and testing processes. In most instances, the specifications and quality of the services have to meet US or European Pharmacopoeia USP EP and approved to use by local Regulatory and International Authorities (US FDA, European Medicines Agency (EMA)).
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The documents will cover the processes in an equipment cGMP Life-Cycle from URS, design, construction, qualification to Maintenance eg:
- Design Specification – User Requirement Specifications, Functional Specification
- Design guidelines and calculation – eg
- E10-01 Design & construction guidelines for a Purified Water System.
- E10-03 Our MS Excel Spreadsheet is a “MUST HAVE” for all facilities having a Purified Water System. It is a simple and inexpensive tool to help you understand your water usage and how to estimate the size of the purified water generator, storage tank and piping.
- Testing, Commissioning & Equipment Qualification protocols
- Operation, Monitoring & Maintenance SOP