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Water System Validation and Phases

Water system validation is very important in pharmaceuticals. Water is used in the manufacturing process in very large quantities during different stages of manufacturing. During manufacturing, water is continuously generated and distributed and can not be tested and analyzed for each and every quantity used in production.

To provide consistent quality standards, It needs to validate for treatment, generation, storage, and distribution. So there is a total of 3 phases for water system validation.

Related: 4 Types Process Validation, Pharmaceutical

Water System Validation Lifecycle:

water system validation lifecycle

3 Types of Water System Validation

  1. Water System Validation Phase 1
  2. Water System Validation Phase 2
  3. Water System Validation Phase 3

1. Water System Validation Phase 1:

The time period for phase 1 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.

Related Topic: Cleaning Validation Protocol for Pharmaceutical Equipment

2. Water System Validation Phase 2:

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 3:

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. Following this review, a routine plan should be established based on phase 3.

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.

Related Post: Difference between Validation, Calibration, and Qualification in Pharma

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.

Tests should be done for the determination of conductivity, PH, heavy metals, nitrates, total organic carbon (TOC), total viable count, presence of the specific pathogen, and endotoxin according to pharmacopeia specifications has been satisfied. Monitoring data should be subjected to trend analysis.

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.


So, if you are establishing a new facility, you will undoubtedly want assistance with water system validation. so for that validation authority should be approved by state drug control and CDSCO, under the Drugs and Cosmetics Act. Also, validation authority must be approved by state drug control and CDSCO. Furthermore, the Central Drugs Standard Control Organization, India’s national regulatory organization for pharmaceuticals and medical devices, has accepted the validation authority.

Q. Why there are requirements for Water system Validation?

It is important that the quality of water should be specific for product quality. Low quality of water can lead to product degradation, contamination, loss of product, and profit.

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