Md. Shoaib Alam

Abstract

The goal of the CGMPs for the 21st Century initiative such as advancing science and technological innovation. Update guidance based on regulatory experience since 1987. Process Validation emphasise on process design elements and maintaining process control during commercialization and communicate that process validation is an ongoing program and align process validation activities with product lifecycle. Process validation also emphasizes the role of objective measures and statistical tools & analyses and emphasizes knowledge, detection, and control of variability and gives assurance on