PHA732 Quality Control/Quality Assurance

[3–0, 3 cr.]

Interpretation and application of the current Good Manufacturing Practices (cGMPs) to drug substance and drug product manufacture. Differentiation between the “Full GMPs” required for commercial manufacturing and “Appropriate GMPs ” required for clinical supplies production. Differences between the US FDA and the European Union’s requirements for the manufacture and control of pharmaceuticals. Quality and compliance function in pharmaceutical and biotechnology companies and current trends in industry. Quality control (QC) role vs. quality assurance (QA) role. Good Laboratory Practices (GLPs). Use of “Graded” approach to manufacture Active Pharmaceutical Ingredients (API’s), with focus on biologics and drugs, discussion of medical device regulations, and aseptic processing. Develop product specifications, writing effective process deviations to be in compliance, and addressing out of specification results.