PHA732 Quality Control/Quality Assurance

[3–0, 3 cr.]

The course will allow students to interpret and apply the current Good Manufacturing Practices (cGMPs) to drug substance and drug product manufacture, differentiate between the “Full GMPs” required for commercial manufacturing and “Appropriate GMPs ” required for clinical supplies production; explore the differences between the US FDA and the European Union’s requirements for the manufacture and control of pharmaceuticals; understand quality and compliance function in pharmaceutical and biotechnology companies and current trends in industry; differentiate between quality control (QC) role vs. quality assurance (QA) role; explain Good Laboratory Practices (GLPs); use “Graded” approach to manufacture Active Pharmaceutical Ingredients (API’s), with focus on biologics and drugs; discuss medical device regulations, and aseptic processing; develop product specifications, write effective process deviations to be in compliance, and address out of specification results.