Water system

Water for pharmaceutical use (WPU), purified water (PW), highly purified water (HPW) and water for injections (WFI) systems are all considered to be direct impact, quality critical systems that should be 

qualified.

The qualification should follow the

 design qualification (DQ), 

 installation qualification (IQ), 

operational qualification (OQ) and 

performance qualification (PQ).

 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 procedures should be included in the testing approach.

• Undertake chemical and microbiological testing in accordance with defined plan.
• Sample the incoming feed-water to verify its quality.
• Sample after each step in the purifi cation process daily.
• Sample at each point of use and at other defi ned sampling points daily.
• Develop appropriate operating ranges.
• Develop and fi nalize operating, cleaning, sanitizing and maintenance procedures.
• Demonstrate production and delivery of product water of the required quality and quantity.
• Use and refi ne the standard operating procedures (SOPs) for operation,  maintenance,      sanitization and troubleshooting.
• Verify provisional alert and action levels.
• Develop and refi ne the 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 refi ned 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 one 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.