Current Good Manufacturing Practices (cGMP)Enrol

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Programme Area: Discipline-Specific Modules

Cluster(s): Applied & Health Sciences

Institution: Ngee Ann Polytechnic

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Delivery Mode: Self-paced

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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