Abstract

A REVIEW ON PHARMACEUTICAL VALIDATION AND PROCESS CONTROL AS QUALITY ASSURANCE TOOL

Badri Sireesha*, Basu Venkateswara Reddy, L. Aparna, K. Renuka Devi, B. Ravi Teja and B. Keerthana

ABSTRACT

Process validation is defined as the collection and evaluation of data, from the process design stage. The documented act of proving that any procedure, process, equipment, material, activity or system actually leads to expected result. Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. Process validation involves a series of activities taking place over the lifecycle of the product and process. Documentation at each stage of the process validation lifecycle is essential for effective communication in complex, lengthy, and multidisciplinary projects.

Keywords: Validation, Documentation, Protocol, Process, Equipment, Evaluation.