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Pharmaceutical Water System Validation Audit Checklist

A comprehensive audit checklist for evaluating pharmaceutical water system validation processes, ensuring regulatory compliance, and maintaining the highest standards of water quality for pharmaceutical manufacturing.

Pharmaceutical Water System Validation Audit Checklist
by: audit-now
4.6

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About This Checklist

Water is a critical utility in pharmaceutical manufacturing, used as an ingredient, processing aid, and cleaning agent. This Water System Validation Audit Checklist is designed to comprehensively evaluate the validation and ongoing control of pharmaceutical water systems, including Purified Water (PW) and Water for Injection (WFI) systems. By systematically assessing system design, installation, operation, maintenance, monitoring, and quality control processes, this checklist helps ensure the consistent production of water that meets pharmacopoeial and regulatory standards. Regular use of this checklist supports compliance with Good Manufacturing Practices (GMP), enhances product quality, and minimizes risks associated with water-borne contamination in pharmaceutical products.

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Industry

Pharmaceuticals

Standard

USP <1231>, EP 5.1.1, FDA Guidance for Industry on Process Validation, ISPE Baseline Guide: Water and Steam Systems

Workspaces

Pharmaceutical manufacturing plants

Occupations

Water System Specialists
Quality Assurance Managers
Validation Engineers
Microbiologists
Facility Managers

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