The Annexes to the code of GMP apply to Parts I and II, i.e. to the manufacture of cannabis as an active pharmaceutical ingredient as well as to the manufacture of the finished medicinal cannabis product.
All GMP Annexes that are relevant to your manufacturing processes apply. This may depend on the dosage form manufactured, or on specific process characteristics. GMP Annexes that are relevant to the manufacture of all non-sterile medicinal cannabis products are:
Annex 7 - Manufacture of herbal medicinal products
Annex 8 - Sampling of starting and packaging materials
Annex 15 - Qualification and validation
Annex 19 - Reference and retention samples
Annex 20 - Quality risk management
Annex 20 is not mandatory; it is a tool to assist you in satisfying the mandatory clauses 1.5 and 1.6 in Part I of the Code of GMP.
Annexes that may be relevant to the manufacture of medicinal cannabis products, depending on dosage form and process characteristics, are:
Annex 9 - Manufacture of liquids, creams and ointments: only relevant for medicinal cannabis products in these dosage forms
Annex 11 - Computerised systems: only relevant for manufacturing processes or testing activities, where computer systems are used
Annex 13 - Manufacture of investigational medicinal products: only relevant for medicinal cannabis products for use in clinical trials
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.