Abstract

WATER SYSTEMS VALIDATION ASPECTS USED IN MANUFACTURING OF PHARMACEUTICAL PRODUCTS

Abubakar Siddique*, Syed Hamdani Raza and Kashif Ahmed

ABSTRACT

The purpose of carrying out water system validation is to assure that the treatment process produces a water of high quality consistently. In order to achieve pharmaceutical water having desired chemical and microbiological quality as per international guidelines, there is need to validate the water system. The aim of this study is to discuss all about validation including entire water system components, their working on set parameters consistently, equipment qualification (PQ i-e Performance Qualification, OQ i-e Operational Qualification, IQ i-e Installation Qualification & DQ i-e Design Qualification), qualification phases, documentation, re-validation and after validation monitoring.

Keywords: Validation; Water system; re-validation; equipment qualification, pharmaceutical water.