Current Good Manufacturing Practices (cGMP)Enrol
Module Start/End Date: October 14, 2024 to March 31, 2025
Enrollment Period: October 14, 2024 to March 31, 2025
Programme Area: Discipline-Specific Modules
Cluster(s): Applied & Health Sciences
Institution: Ngee Ann Polytechnic
Duration: 24 Weeks
Delivery Mode: Self-paced
Enrollment Eligibility: All
About this Module
This module aims to provide an understanding of current Good Manufacturing Practice (CGMP) regulations for pharmaceutical products, with an overview of the CGMP regulatory standards and requirements in the pharmaceutical industry, starting with the drug development process to the production of the finished drug product. Topics include origins of pharmaceutical products, background and overview of the pharmaceutical industry, importance of CGMP in the pharmaceutical industry, case studies on drug contamination and enforcement of CGMP regulations. The following topics will be covered: Drugs, pharmaceuticals and biopharmaceuticals and their origins Background and evolvement of the worldwide and Singapore pharmaceutical industry Drug development process Drug manufacturing process Importance of CGMP and regulation of the pharmaceutical industry History of FDA and case studies related to food and drug contamination Importance of CGMP in protecting consumer and businesses Global CGMP Regulations Enforcement of CGMP regulations and actions for non-compliance