Good Practice (GxP) in Drug Development and Manufacturing

Dive into this short module of Good Practices (GxP) for drug development and manufacturing. This module also touches on Good Manufacturing Practices (GMPs), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). This short entry-level course introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). The course covers:

• Drug development and manufacturing – This session outlines the process of drug development and manufacture, from the discovery of new molecules, through nonclinical studies and clinical trials, to marketing approval application, manufacturing scale-up and quality management, and pharmacovigilance.
• Regulation of the industry – This session outlines the regulation of the industry, introducing the learner to regulatory authorities and other sources of guidance on GMP, GCP and GLP.

Learn:

• How the drug industry operates
• To understand drug industry regulations
• To identify regulatory authorities