Apr 24, 2024  
2021/2022 University Catalog 
    
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2021/2022 University Catalog [ARCHIVED CATALOG]

R A 770 - Current Good Manufacturing Practices - General Concepts

Units: 3

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.