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

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

Interview Question #037 - 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.



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