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Review Article


 

Validation Aspects of Water Treatment Systems for Pharmaceutical Products

 

Rakesh Pahwa1*, Mona Piplani1, Prabodh C Sharma1 and Arun Nanda2

1Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra-136119, 2Department of Pharmaceutical Sciences, Maharshi  Dayanand University, Rohtak-124001, India

*Corresponding author:  E-mail: rakesh_pahwa2407@yahoo.co.in  Tel : +91-9896250793

Received: 29 June 2009                                                Revised accepted: 30 October 2009

Tropical Journal of Pharmaceutical Research, February 2010; 9(1): 81-90

 

Abstract

 

The goal of conducting validation is to demonstrate that a process, when operated within established limits, produces a product of consistent and specified quality with a high degree of assurance. Validation of water treatment systems is necessary to obtain water with all desired quality attributes. This also provides a framework to establish a total control over the process which monitors safety, efficacy and ultimately, the process outcomes. The present overview is an attempt to discuss various aspects of validation including different approaches, components of water treatment systems, equipment qualifications, phases of performance testing, documentation and post-validation monitoring.

Keywords: Validation; Water treatment systems; Quality attributes; Pharmaceutical products.

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