STEPS OF WATER SYSTEM QUALIFICATION

Steps of Water System Qualification in Pharma

Qualification of a pharmaceutical water system (Purified Water / WFI) is done in a structured, documented sequence to prove that the system is designed, installed, operated, and performs consistently as per GMP.

1. URS, Design & Risk Assessment (Pre-Qualification)

• Prepare User Requirement Specification (URS) – capacity, quality (PW/WFI), temperature, storage volume, loops, sanitization method, regulatory standards (IP/BP/USP/EP).
• Do a design review – P&IDs, material of construction (SS 316L), slopes, dead-leg criteria, velocities, drainability, vent filters, instrumentation.
• Perform a risk assessment (e.g., 6M, FMEA) to identify critical parameters: temperature, flow, sanitization frequency, sampling points, biofilm risk, etc.
• Approve all drawings and technical specs before fabrication.

2. Installation Qualification (IQ)

Objective: Verify that the system is installed as per approved design and manufacturer’s recommendation.

Typical IQ activities:

• Check equipment and components against approved BOM and P&IDs.
• Verify material of construction, surface finish, gaskets, valves, weld logs, slopes, and drain points.
• Verify proper installation of tanks, heat exchangers, pumps, distribution lines, filters, instruments.
• Check instrument calibration (conductivity, TOC, temperature, pressure sensors).
• Confirm tag numbers, labels, and flow direction arrows.
• Compile IQ report with deviations and resolutions.

3. Operational Qualification (OQ)

Objective: Demonstrate that the system operates as intended over the defined operating ranges.

Typical OQ activities:

• Test start-up, shutdown, normal, and worst-case operations.
• Challenge control logic: interlocks, alarms, trips, set points (temperature, conductivity, level, pressure).
• Verify sanitization cycles (hot water/steam/chemical): parameters, time, temperature, sequence.
• Verify system drainability and dead-leg flushing.
• Conduct short-term trial runs and document trend data (temperature, conductivity, TOC where applicable).
• Prepare and approve OQ report.

4. Performance Qualification (PQ) – Phase 1, 2 & 3

PQ proves consistent performance over time under routine conditions. Usually divided into 3 phases.

Phase 1 – Intensive Monitoring (Start-Up)

• Duration: typically 2–4 weeks (as per site procedure).
• Run the system continuously as per routine SOPs.
• Very frequent sampling (e.g., daily from all key points: generation, tank, return loop, user points).
• Test for chemical, microbiological, TOC, conductivity, endotoxin (for WFI).
• Adjust parameters, sanitization frequency, and procedures based on data.
• Goal: stabilize operation and identify any initial issues.

Phase 2 – Routine Operation with Monitoring

• Duration: usually 2–4 weeks.
• Operate the system by trained users under finalized SOPs (operation, cleaning, sanitization, sampling).
• Continue frequent sampling, but pattern may be slightly optimized.
• Demonstrate that the system remains under control without major intervention.

Phase 3 – Long-Term Performance

• Duration: typically 3–12 months (as per company validation policy).
• Sampling as per routine monitoring plan (e.g., weekly from user points, daily from critical points).
• Show consistent compliance with specifications across seasons, load variations, and normal maintenance.
• Final PQ summary report concludes suitability of the water system.

5. Final Documentation, Handover & Ongoing Control

• Compile VMP, URS, DQ, IQ, OQ, PQ reports, trend charts, deviations and CAPA.
• Formally approve the system for GMP use.
• Implement ongoing routine monitoring, periodic sanitization, trending of data, and requalification (e.g., annually or after major changes).