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  1. In the qualification of pharmaceutical water system consist three phases.

Phase-1

Phase-2

Phase-3

Phase-1: In this phase continuously monitor water system period of 2-4 eeks. In this period should monitor and operate tests continuously without failure or performance deviation. In this phase water should not use for the pharmaceutical manufacturing.

The following tests should perform in this phase.

  • Sample each step of purification daily.
  • Daily sample each point of use.
  • Should perform the microbial and chemical tests as per plan.
  • Daily should sample incoming feed water and verify the quality of water.
  • Develop desired operating ranges of water system.
  • Demonstrate the production and delivery of purified water of required quantity and quality.
  • Prepare and follow the SOP’s for operation, maintenance, sanitization and problem rectification (trouble shooting) of water system.
  • Develop and monitor test failure and actions required for problem solving procedure.
  • Verify the provisional alert and action level.

                      Phase-2: In this period water can use for the production. This phase test period is for 2-4 weeks. Sampling procedure is same as Phase-1.

  • Demonstrate the production and delivery of purified water of required quantity and quality
  • Demonstrate operate the water system with established range.

Phase-3: This phase will start after successful completion of Phase-2 in this phase water can use for manufacturing.

  • In this phase should ensure seasonal variations are evaluated’
  • Demonstrate extensive reliable performance
  • Reduce sample locations and frequency of sampling as per phase-1 and phase-2
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