How many phases are in performance qualification of purified water system?

Performance qualification of the purified water system is divided into the three phases as described below:

Phase-I:  Develop & finalize operating procedure, preventive maintenance and sanitization procedures. Demonstrate production & delivery of water of required quality. To finalize SOP on sanitization of the water system, Alert & Action limits. Phase – I is conducted for 14-28 days.

Phase-II: Demonstrate consistent operation within established ranges. Demonstrate consistent production & delivery of water of required quality (pharmacopeia). Phase – II is conducted for 14-28 days.

 Phase-III: Demonstrate extended performance of the water system. Ensure that potential seasonal variations are evaluated & treated. Phase-III is conducted for 10-12 months.