Mar 10, 2025  
2023/2024 University Catalog 
    
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2023/2024 University Catalog [ARCHIVED CATALOG]

R A 770 - Current Good Manufacturing Practices - General Concepts

Units: 3

Grading Method: LTR: Letter Graded. The class will be offered for letter grade with no option to take it for Cr/NC

Prerequisite(s): R A 602 .

Interpretation and application of current Good Manufacturing Practices (GMPs) to drug substance and drug product manufacture. Differentiation between full and appropriate GMPs required for clinical supplies production and commercial manufacturing. Variances between FDA and European Union requirements for the control and manufacture of pharmaceuticals. Aseptic regulatory inspections processing and preparation.

Maximum Credits: 3