Water System Validation in Pharmaceutical Industry

3 Types of Water System Validation:
  • Water System Validation Phase I
  • Water System Validation Phase II
  • Water System Validation Phase III

1. Water System Validation Phase I
The time period for phase I shall be 2 to 4 weeks (14 days minimum) to Examine the system thoroughly. During this time, the operation must operate continuously without fail or performance modification. Before starting Phase 1, The challenge test should be done for the auto Dump valve and hold Time study. During the Phase 1 validation drain Time study is also to be done.

The following should be included within the testing approach:
  • Verify its quality by sampling daily from sampling Points.
  • Take the sample stepwise after each step of purification.
  • Take the daily samples from the point of use of water.
  • Develop suitable operating ranges.
  • Develop a maintenance procedure and operating cleaning sanitization.
  • Demonstrate the production and delivery of product water of the required quantity and quality.
  • Use and refine the SOP for operation, maintenance, sanitizing, and troubleshooting.
  • Verify provisional alerts and action levels.
  • Develop and refine the test-failure procedure.

2. Water System Validation Phase II
Validation phase 2 is a period of 2 to 4 weeks (30 days) to spend carrying out further intensive monitoring. The sampling plan should be the same as in Phase 1. During this phase, water can be used for the production process.

It Shows that demonstrates should be done for consistent production and delivery of water of the required quantity and quality. When the system is operated as per the standard operating procedure.

3. Water System Validation Phase III
After completion of Phase 1 and Phase 2, Phase 3 is typically run for one year. During this phase, water can be used for manufacturing purposes.

  • During phase 3, the sample locations, sampling frequencies, and therefore the test should be reduced to normal routine patterns supported by established procedures proven during Phase 1 and phase 2.
  • Ensure that seasonal variations are evaluated.
  • After completion of Phase 3 of the qualification program for the water purification unit system, a systematic review should be undertaken.

Monitoring should include a combination of online instrument monitoring of parameters such as flow, pressure, temperature, conductivity, and total TOC, and simple offline testing for physical-chemical and microbial attributes.

Offline samples should be taken from the point of use and specific simple points. Sample from the point of use should be taken in a similar way to that adopted when the water is being used in service.

Revalidation of the water system should be carried out if there is a major change in the system, the addition or removal of any loop from the system, a change of location, system modification, or any other reason which affects the water quality.

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