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Life-Sciences eQMS 19 items

Pharmaceutical Water System Monitoring & Control Checklist (USP <1231>)

Assesses design, monitoring, and control of pharmaceutical water systems producing Purified Water and Water for Injection. Use for periodic system review and monitoring program verification.

USP <1231>USP <645>USP <643>21 CFR 211.113

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System Design and Materials

  • Is the water system designed to minimize dead legs and promote continuous circulation/turbulent flow? *
  • Are wetted materials of construction compatible and documented (e.g., 316L stainless steel, appropriate polymers)? *
  • Is the distribution loop maintained under conditions that control biofilm (e.g., hot circulation or continuous ozonation)? *
  • Are points of use fitted with appropriate sampling and drainage design? *

Chemical Quality Monitoring

  • Is conductivity monitored and within the stage limits of the compendial method? *
  • Is Total Organic Carbon (TOC) monitored and within limits? *
  • Record the most recent point-of-use conductivity result.
  • Are online instruments calibrated and their calibration status current? *

Microbial and Endotoxin Control

  • Are microbial action and alert levels established and monitored for each water grade? *
  • For Water for Injection, is bacterial endotoxin monitored against the NMT 0.25 EU/mL limit? *
  • Are sampling frequency and locations defined in a written monitoring program? *
  • Are excursions beyond alert/action levels investigated and trended? *

Sanitization and Maintenance

  • Is the system sanitized (thermal, chemical, or ozone) at a validated, documented frequency? *
  • Are filters, UV lamps, and RO/EDI units maintained and replaced per schedule? *
  • Record the date of the last full-loop sanitization.
  • Is preventive maintenance documented in equipment logs? *

Data Review and Qualification Status

  • Is the system's qualification (Phases 1, 2, 3) complete and periodic requalification current? *
  • Are trend reviews of chemical and microbial data performed at a defined frequency? *
  • Is water quality confirmed suitable for its intended manufacturing use? *

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