Tropical Journal of Pharmaceutical Research

Review Article | OPEN ACCESS

Validation Aspects of Water Treatment Systems for Pharmaceutical Products

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

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

For correspondence:- Rakesh Pahwa Email: rakeshpahwa2407@yahoo.co.in Tel:+919896250793

Received: 29 June 2009 Accepted: 30 October 2009 Published: 23 February 2010

Citation: Pahwa R, Piplani M, Sharma PC, Nanda A. Validation Aspects of Water Treatment Systems for Pharmaceutical Products. Trop J Pharm Res 2010; 9(1):81-90 doi: 10.4314/tjpr.v9i1.11

© 2010 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

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