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Validation of Purified Water System with Risk Based Approach – A Review

Received On: 24/08/2015
Accepted On: 04/09/2015


Sharma, M., Sharma, A., Sharma, R.B., Aggarwal, S.

Author's Affiliation


Water is essential for industrial, pharmaceutical and hospital purposes, in the preparation and processing of medicines and other health products and for cleaning and hygiene purposes. Water purification systems must be validated to insure that the specified quality of water is consistently produced for use of all purpose as well as formulation, production, analysis, drinking cleaning and to solve the problems arising in the purification system. Validations of water purification system are performed in three phases by applying various chemical and microbiological tests. Risk assessment is required for every process, equipments, production, etc., in pharmaceutical industry. The aim of the risk assessment process is to remove hazards or reduce the level of its risk by adding Precautions or control measures. Risk assessments are very important as they form on integral part of a good occupational health and safety management plan. They help to create awareness of hazards and risks, Prevent injuries and illnesses when done at the design or planning stage. Qualification plays an important role in validation of purified water system. There are Installation, Operational, and Performance Qualification protocol of purified water storage and distribution system. The FMEA (Failure Mode Effects Analysis) tool complies with the cGMP aspects and meets the regulatory requirements. By this FMEA we can mitigate the risk and controls the probable failure moods of any new facility, equipment or system. So the deliverable capacity can be maintained consistently without any complains and system will work for longer period without any failure moods as per its pre defined specification or regulatory requirements.


Purified Water System, Validation, Qualification with Risk Based Approach, Commissioning, Risk Assessments, Failure Mode Effects Analysis Bilayer

Cite This Article

Sharma, M., Sharma, A., Sharma, R.B., Aggarwal, S. (2015). Validation of Purified Water System with Risk Based Approach - A Review, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(3), 139-149.

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