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GxP guidelines are quality guidelines containing guidance and regulations for each operation in a pharmaceutical industry. The global pharmaceutical regulatory agencies and healthcare organizations like the Food and Drug Administration (FDA), World Health Organization (WHO), European Medicines Agency (EPA), and International Council for Harmonization (ICH) have standard GxP guidelines for manufacturing, testing, distribution, and documentation, etc.
This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Introduction to GxP guidelines
Lesson 2: The many faces of GxP
Lesson 3: Good Manufacturing Practice (GMP)
Lesson 4: Good Laboratory Practice (GLP)
Lesson 5: Good Distribution Practice (GDP)
Lesson 6: Good Clinical Practice (GCP)
Lesson 7: Good Documentation Practice (GDocP)