ICH Guideline Q11 Development AND Manufacture Drug Substances Chemical Entities AND Biotechnological Biological Entities
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/ich-guideline-q11-development-and-manufacture-drug-substances-chemical-entities-and-biotechnological-biological-entities
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