2023 GMS5004 Regulation of Pharmaceutical Manufacturing

Ensuring quality of healthcare products is one of the key pillars in regulatory responsibilities, for industry, manufacturers and regulators. The contribution of Chemistry, Manufacturing and Controls (CMC) to a successful control of quality in pharmaceutical products spans from product development and manufacture, process validation to post-market variation changes, as well as an optimal quality management system. 

This module provides the foundation in understanding the regulatory science behind the development, manufacturing and control of pharmaceuticals, including the global guidances that shapes the regulatory processes.  Besides promoting good submissions and evaluation practices, the module aims to enhance regulatory convergence and cooperation on CMC regulation.