Abstract

PROCESS VALIDATION FOR PHARMACEUTICAL AND BULK PRODUCTS: A REVIEW

*R. N. Pal, A. Sarkar and M. Chakraborty

Abstract

Process Validation Is Important to assure the quality and regulatory requirements for manufacturing of pharmaceutical products as well as bulk products. It is also required for Optimized processes, reduced cost of maintaining quality, increased output., reduced complaints, rejections, batch failure, mix-ups, and cross-contamination, faster scale-up from pilot level to the manufacturing level., better compliance with regulatory requirements. It is specifically referred to in EU Directives and EU GMP. It is a requirement according to CFR and ICH Q guidelines. It is a basic principle of GMP as per schedule M under Indian Drugs and Cosmetics Act 1940.

Keywords: GMP(Good Manufacturing Practices), CFR(Code Of Federal Regulation), ICH(International Conference on Harmonization), Pilot, FDA(Food and Drug Administration)