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Medicinal cannabis manufacture

Technical guidance on the interpretation of the PIC/S Guide to GMP

10 December 2019

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Annexes of the PIC/S Guide to GMP

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

Please note

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

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