TGA Good Manufacturing Practice (GMP) Guidelines for Medicinal Products - Part II
Click the titles below for complete guidelines
Contents
8. Production and in-process
controls
9. Packaging and identification
labelling of APIs and intermediates
14. Rejection and re-use of
materials
16. Contract manufacturers
(including laboratories)
17. Agents, brokers, traders,
distributors, repackers and relabellers
18. Specific guidance for APIs
manufactured by cell culture / fermentation
19. APIs for use in clinical
trials