Quality Risk Management for Pharmaceutical Water Systems: Hazards, Critical Control Points and Control Strategy
Many water system risk assessments describe the plant without deciding anything. Here is how to identify hazards and...
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From water quality definition to generation, distribution, qualification and lifecycle management. A GuideGxP technical area dedicated to PW and WFI systems in GMP facilities.
Technical content, operational tools and specialist support organised around the real decisions involved in a Pharmaceutical Water or WFI project.
Pretreatment, RO, EDI, UF, distillation and PW/WFI generation strategies.
Tanks, loops, hygienic piping, materials, points of use and sanitisation.
TOC, conductivity, microbiology, instrumentation, automation, alarms and data.
DQ, FAT/SAT, commissioning, IQ/OQ/PQ, maintenance, periodic review and retrofit.
Identify the activities, decisions and evidence required at each stage of your Pharmaceutical Water or WFI project.
Define intended use, water quality, design basis, capacity, URS and risks.
Design pretreatment, generation, storage, distribution, materials, instrumentation and automation.
Build and install equipment, piping, instruments, software and infrastructure while maintaining hygienic design and documentation.
Execute DQ, FAT/SAT, commissioning, IQ/OQ/PQ, CSV and requirements traceability.
Manage sampling, TOC, conductivity, microbiology, sanitisation, trending and maintenance.
Manage periodic review, deviations, biofilm, rouging, change control, retrofit and lifecycle improvement.
The Project Library connects each stage of the project with relevant GuideGxP technical content. New articles appear automatically when they are published.
Define intended use, water grade, URS, design basis and Quality Risk Management.
Compare pretreatment, RO, EDI, UF, distillation and PW/WFI generation strategies.
Design tanks, loops, hygienic piping, materials, points of use and sanitisation.
Build a coherent strategy for TOC, conductivity, microbiology, instrumentation, automation and the data lifecycle.
Turn design and installation into evidence through DQ, FAT/SAT, commissioning, IQ/OQ/PQ and CSV.
Maintain the system in control and govern investigations, supplier selection, periodic review, retrofit and TCO.
A 256-page operational guide covering intended use, water quality, URS, QRM, generation, storage and distribution, instrumentation, automation, commissioning, qualification, sampling, sanitisation, microbiology, troubleshooting and lifecycle management.
Water quality, design, qualification and data governance should clearly distinguish pharmacopoeial requirements, GMP expectations, guidance, technical standards and good engineering practice.
Selection of the appropriate water quality for pharmaceutical use and application of European expectations.
Monographs and applicable chapters covering Purified Water, Water for Injection, TOC, conductivity, endotoxins and microbiological control.
URS, DQ, FAT/SAT, commissioning, IQ/OQ/PQ, change control and lifecycle qualification.
Automation, electronic records, access control, audit trails, data integrity, backup, restore and periodic review.
Describe the water quality, system configuration, project stage and support required. GuideGxP will review the request and, where appropriate, may connect you with a specialist matched to the technical scope and geography.