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Manufacture of medicinal cannabis for supply under 'approved access' provisions

Guidance on GMP compliance

2 January 2018

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Further technical GMP guidance

The requirements of the PIC/S Guide to GMP apply, unless the specific requirements are not applicable to the specific manufacturing activity, or equivalent level of compliance is achieved by alternative means. Any omission or alternative approach to compliance must be based on quality risk management principles. Where products are made for use in clinical trials the principles under Annex 13 should be considered.

The following technical guidance documents have been developed for the application of quality risk management in the manufacture of complementary medicines. Subject to the principles of quality risk management and Annex 13 of the PIC/S Guide to GMP, the documents contain information that may assist you in the application of quality risk management for the manufacture of medicinal cannabis products to be made available via clinical trials or investigational product pathways.

Once medicinal cannabis products are registered on the ARTG, approved access provisions will no longer apply and therefore these technical guidance documents may no longer be relevant.

Stability

Ongoing stability would not normally be applicable for the manufacture of a medicine for use in a clinical trial. However, stability would be required according to Annex 13 and in support of expiry date for the material. The clauses in Annex 13 that would be applicable for stability of a medicine that is manufactured for use in a clinical trial include 6, 9, 20, 26j and 40.

Product quality review

Please note

The TGA interpretation and expectations for demonstrating compliance with PIC/S PE009-13 includes additional information on the preparation of PQRs, which is applicable to the manufacture of medicinal cannabis products.

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