Pharmaceutical Water System Inspection Checklist
Pharmaceutical water is a critical utility and raw material for drug manufacturing. This monthly inspection checklist ensures PW and WFI systems meet USP <1231> quality standards and are properly monitored and maintained.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Monthly
- Estimated Time: 30-45 minutes
- Role: Validation Engineer / QA Manager
- Total Items: 31
- Compliance: USP <1231> Water for Pharmaceutical Purposes, FDA 21 CFR 211.67 Equipment Cleaning and Maintenance, EU GMP Chapter 3.41 Water Systems, ISPE Baseline Guide Volume 4 - Water and Steam Systems
Pre-Treatment System
Inspect incoming water pre-treatment.
- Municipal feed water meeting potable water standards (tested per schedule)?
- Activated carbon filter replacement current and chlorine removal verified?
- Water softener or dealkalizer regeneration current?
- Sediment filters within replacement schedule?
- UV disinfection lamp intensity monitoring current?
Purification System (RO/EDI/Distillation)',
Inspect water purification equipment.
- Reverse osmosis (RO) rejection rate within performance specification?
- EDI or mixed bed DI unit conductivity within specification?
- WFI still producing WFI within conductivity and endotoxin specs?
- Water storage tank level and pressure within normal range?
- Tank vent filter hydrophobic and within replacement schedule?
Distribution Loop
Inspect water distribution system.
- Water circulating continuously at turbulent flow rate?
- No newly installed dead legs or unmonitored branches?
- Loop temperature within specification (hot loops ≥70°C; cold loops ≤25°C)?
- All points of use included in sampling plan?
- All loop valves and drains in good condition with no leaks?
Quality Testing and Specifications
Review water quality testing results.
- Conductivity results within USP specification (PW ≤1.3 µS/cm, WFI ≤1.3 µS/cm)?
- TOC results within USP specification (≤500 ppb)?
- Microbial counts within USP and site action limits?
- WFI endotoxin ≤0.25 EU/mL per USP <85>?
- No out-of-specification or action limit exceedances in current period?
Sanitization and Maintenance
Verify sanitization program compliance.
- Sanitization performed per qualified schedule (heat, chemical, or ozone)?
- Sanitization records complete with parameters and results?
- Preventive maintenance current for all water system components?
- In-line conductivity, TOC, and temperature instruments calibrated?
- Biofilm control strategy documented and effective?
Qualification and Documentation
Verify water system qualification is current.
- Water system qualification current with Phase I/II/III validation completed?
- No unqualified changes made to the water system?
- Monthly water quality trend review completed?
- Sampling plan current with all critical points included?
- Water system incident log current?
- Annual water system review completed per validation protocol?
Related Pharmaceutical Life Sciences Checklists
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- Pharmaceutical Microbiological Contamination Testing Checklist
- Pharmaceutical QC Laboratory Inspection Checklist
- Pharmaceutical Supplier Qualification Audit Checklist
- Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist
- Pharmaceutical Packaging Materials Audit and Inspection Checklist
- GxP Training Compliance and Competency Audit Checklist
Related Laboratory Checklists
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Why Use This Pharmaceutical Water System Inspection Checklist?
This pharmaceutical water system inspection checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for validation engineer / qa manager professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: monthly.
Ensures compliance with USP <1231> Water for Pharmaceutical Purposes, FDA 21 CFR 211.67 Equipment Cleaning and Maintenance, EU GMP Chapter 3.41 Water Systems, ISPE Baseline Guide Volume 4 - Water and Steam Systems. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Water System Inspection Checklist cover?
This checklist covers 31 inspection items across 6 sections: Pre-Treatment System, Purification System (RO/EDI/Distillation)',, Distribution Loop, Quality Testing and Specifications, Sanitization and Maintenance, Qualification and Documentation. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 30-45 minutes.
Who should use this Pharmaceutical Water System Inspection Checklist?
This checklist is designed for Validation Engineer / QA Manager professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.