Abstract

A REVIEW ON PHARMACEUTICAL VALIDATION & PROCESS CONTROL AS QUALITY ASSURANCE TOOLS

Vaghela Kuldeepsinh*, Maisuriya Aakash, Mitali Dalwadi, Dr. Chainesh Shah and Dr. Umesh Upadhyay

ABSTRACT

Process validation is fitting documented proof which supplies a high degree of affirmation that a specific procedure, method can compactly deliver a product or result meeting its preset specifications and quality attributes. Validation is the key method for effective Quality Assurance. Objectives square measure primarily to assure that the specific drug product have the identity, strength, quality and purity. and therefore the next is to determine that a method systematically performs or not. As per GMP validation protocols square measure basic items of GMP these square measure needed to be done in step with predefined conventions, the base that need to be approved incorporate method, testing and cleansing later such control methodology, establish to screen the yield and approval of aggregation forms that might be guilty of fluctuation of medication item. The analysis of validation method gives North American country the exactness, accuracy, specificity and dependableness of the check techniques used by the organizations, may well be engineered up and archived. consequently the validation could be a fundamental piece of the standard affirmation or assurance.[1]

Keywords: GMP, Quality Assurance, Pharmaceutical Validation, Pharmaceutical method Control.[1]