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.