Current Good Manufacturing Practices

Course Description

This course is specifically designed for undergraduate-level students with no industry experience, introducing them to 1) the concept and requirements of the regulated pharmaceutical and biopharmaceutical industries, and 2) the "cGMPs" (or current good manufacturing practices), which refer to the specific regulations and guidances of the U.S. Food and Drug Administration (FDA) that must be followed in the manufacturing of all regulated pharmaceutical products. The course provides an overview of the concepts of "quality assurance," "regulatory affairs," and "compliance" which govern every aspect of the pharmaceutical, biopharmaceutical and related industries which are employed and followed to assure that consistency and quality outcomes are obtained. Since this is an introductory course, time will be spent defining and explaining commonly used industry terminology and acronyms. Class discussions will focus on the regulations for drugs that appear in the Food, Drug and Cosmetic Act (21 CFR 210 and 211), and how these are applied to every aspect of the manufacturing process, including personnel, buildings, equipment, and records. Class workshops will enable students to write and critique the creation of SOPs (standard operating practices) for GMPs and also delve into the consequences if companies are non-compliant with the GMPs.

Code

PS 3477

Credits

3

Subject

PS

Programs That Include This Course

• Bachelor's Bachelor of Science in Pharmaceutical Sciences