Current Good Manufacturing Practices and Quality Assurance
GMS BT 240
Prereq: BT 110 (Intro Biomed Lab Sci). This course provides a detailed knowledge of the role of Current Good Manufacturing Practices (CGMPs) and a Quality Department in the development and manufacture of biopharmaceutical products. Topics include the goals and obligations of the Food and Drug Administration (FDA), a review of the CGMP subparts, and the responsibilities of a Quality Department in ensuring product quality. CGMPs are the FDA's minimal requirements for manufacturing, processing, packing, and holding of a drug product. Emphasis is on understanding the intent and practical application of these regulations. Topics include the regulations and historical perspective, quality control concepts, case studies and examples of FDA enforcement.