Purified Water System Validation : Pharmaceutical Guidelines https://www.pharmaguideline.com/2012/07/purified-water-system-validation.

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Purified Water System Validation : Pharmaceutical Guidelines https://www.pharmaguideline.com/2012/07/purified-water-system-validation.html

Purified Water System Validation

Commissioning, qualification, first, second and third phases of validation, their documentation and sampling schedule in purified water system validation.
Water system validation (generation and distribution) should contain three phases: Phase I: investigation phase; Phase II: short-term con
Phase III: long-term control.

The objective of pharmaceutical water system validation during these three phases should demonstrate that water system is under con
producing the specified quality of water over a long time period.

Related: Reverse Osmosis System for Water Purification

Commissioning of purified water system

Proper documentation of commissioning is an essential part of the successful validation of pharmaceutical water system. Commissioning inc
the startup of the water system with documenting the performance of all system parameters.

Qualification
Purified water, water for pharmaceutical use, water for injection systems can directly affect the quality of our pharmaceutical products. H
should be validated. Before starting the validation, water system qualification should be completed i.e. design qualification (DQ), ins
qualification (IQ) and operational qualification (OQ).

Phase I:
Water sampling and testing should be done for 2 to 4 weeks to monitor the water system. During this phase, water system should
continuously without failure. Following things should be considered during this phase.
• Sampling and testing of the raw water i.e. feed water should be done to monitor its quality.
• Sampling after each step should be done daily.
• Chemical and microbiological testing should be done as per the approved specification.

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