Pharmaceutical water systems are among the most critical utilities influencing product quality, cleaning processes, and sterile operations. PrimeGMP provides comprehensive qualification of PW, WFI, and water distribution loops to ensure compliance with global regulatory standards and consistent delivery of microbiologically and chemically controlled water.

1. Design Qualification (DQ)

• Review of URS, P&ID, isometrics, and OEM design documents
• Assessment of pretreatment units: softener, RO, MMF, ACF, UV, EDI/RO modules
• Evaluation of WFI generation systems: MWS (Multi-Effect), VLS stills
• Verification of sanitary design, pump capacity, loop velocity (≥1.0–1.5 m/s)
• Review of drainability, slopes, dead-leg criteria (< 1.5D), loop temperature control
• Material of construction verification (SS316L), orbital welding, surface finish (Ra)
• Risk assessment as per ICH Q9
• Compliance with USP <1231>, Ph. Eur., WHO, ISPE Baseline Guide

2. Installation Qualification (IQ)

• Inspection of pretreatment, RO, EDI, UV, storage tank, and distribution loop
• Verification of pumps, heat exchangers, vents, breather filters, sampling points
• Calibration of pressure, temperature, conductivity, and TOC instrumentation
• Verification of return line, slopes, and drainability
• Review of weld logs, passivation certificates, MOC certificates
• FAT / SAT review and documentation verification

3. Operational Qualification (OQ)

• System start-up and operating parameter verification
• Conductivity and TOC analyzer functional checks
• Review of alarm and interlock functionality
• Sanitization cycle verification (thermal/chemical)
• Conductivity response time testing
• Flow, pressure, and temperature stability checks
• Verification of recirculation velocity and loop balance
• UV lamp intensity checks and filter integrity (where applicable)

4. Performance Qualification (PQ)

30-Day or 14-Day PQ Program (as required)

Chemical Testing

• Conductivity
• TOC
• pH
• Nitrate / Chlorides (where applicable)
• Hardness / Silica (pretreatment)

Microbiological Testing

• Total microbial count
• Endotoxin testing (WFI)
• Biofilm monitoring at critical points

Point-of-Use Testing

• Sampling at all user points following worst-case schedule
• Monitoring of:
  • Temperature
  • Conductivity
  • TOC
  • Microbial load
  • Endotoxin (WFI)
• Return line quality verification

Thermal/ Chemical Sanitization Verification

• Cycle validation and hold time study
• Temperature mapping and cycle reproducibility

Documentation Provided

• DQ / IQ / OQ / PQ Protocols & Reports
• 30-Day PQ Data Summary
• Microbial & Endotoxin Test Reports
• Conductivity / TOC Trending Charts
• Calibration Certificates
• Weld Log & Passivation Certificates
• Sampling Plans & SOPs
• Final Validation Summary Report

Regulatory Standards Followed

• USP <1231> Water for Pharmaceutical Purposes
• USP <643> TOC, USP <645> Conductivity
• Ph. Eur. Monographs – PW, HPW, WFI
• WHO TRS 961 / 1019
• EU GMP Annex 1 & Annex 15
• ISPE Baseline Guide – Water & Steam Systems
• USFDA 21 CFR 210/211

Why Choose PrimeGMP for Water System Qualification?

• Expertise in PW, HPW, WFI, and loop systems
• Use of calibrated instruments for accurate TOC/conductivity data
• Strong understanding of microbial control and sanitization cycles
• Thorough sampling and trending across all user points
• Audit-ready documentation and regulatory-focused approach
• Troubleshooting support for tank temperature, biofilm control, and loop balance