7.2 Qualification

WPU, PW, HPW and WFI systems are all considered to be direct impact, quality critical systems that should be qualified. The qualification should follow the validation convention of design review or design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).

This guidance does not define the standard requirements for the conventional validation stages DQ, IQ and OQ, but concentrates on the particular PQ approach that should be used for WPU systems to demonstrate their consistent and reliable performance. A three-phase approach should be used to satisfy the objective of proving the reliability and robustness of the system in service over an extended period.

Phase 1. A test period of 2-4 weeks should be spent monitoring the system intensively. During this period the system should operate continuously without failure or performance deviation. The following should be included in the testing approach.

• Undertake chemical and microbiological testing in accordance with a defined plan.

• Sample the incoming feed-water daily to verify its quality.

• Sample after each step in the purification process daily.

• Sample at each point of use and at other defined sample points daily.

• Develop appropriate operating ranges.

• Develop and finalize operating, cleaning, sanitizing and maintenance procedures.

• Demonstrate production and delivery of product water of the required quality and quantity.

• Use and refine the standard operating procedures (SOPs) for operation, maintenance, sanitization and troubleshooting.

• Verify provisional alert and action levels.

• Develop and refine test-failure procedure.

Phase 2. A further test period of 2-4 weeks should be spent carrying out further intensive monitoring while deploying all the refined SOPs after the satisfactory completion of phase 1. The sampling scheme should be generally the same as in phase 1. Water can be used for manufacturing purposes during this phase. The approach should also:

- demonstrate consistent operation within established ranges; and

- demonstrate consistent production and delivery of water of the required quantity and quality when the system is operated in accordance with the SOPs.

Phase 3. Phase 3 typically runs for 1 year after the satisfactory completion of phase 2. Water can be used for manufacturing purposes during this phase which has the following objectives and features.

• Demonstrate extended reliable performance.

• Ensure that seasonal variations are evaluated.

• The sample locations, sampling frequencies and tests should be reduced to the normal routine pattern based on established procedures proven during phases 1 and 2.