Production (Chapter 5, Part I - finished dosage form)

Medicine production

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.

Refer to the technical GMP guidance documents, developed for the application of quality risk management in the manufacture of complementary medicines, noted previously. These documents contain information that may assist you in the application of quality risk management for the manufacture of unapproved medicinal cannabis products to be made available via clinical trials or the other access pathways.

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

Labelling and packaging

Label counting and verification

Roll labels must be counted either on receipt or at issue. Supplier counts are not acceptable unless the supplier is specifically qualified and the supplier certifies the exact count for each roll. Supplier sequential numbering on the backing web of labels is an acceptable alternative.

Cut labels must be counted and effectively verified by the manufacturer because of risks of mix-ups.

Unique batch numbering

The system that a manufacturer adopts for batch numbering may include numerals, letters or symbols (or any combination of these) and must effectively serve to identify uniquely a batch of product, and from which it is possible to trace that batch through all stages of manufacture and distribution. The manufacturer should be able to demonstrate that the system for batch numbering meets these requirements and is effective.

Unpacked bulk products, should have a batch number that is unique to both product and batch, to minimise the potential for mix-ups during manufacturing. For finished products which are easily distinguished, a batch numbering system that only designates batches from that product may be acceptable.

The topic of batch numbering is dealt with in:

• Medicines labels: Guidance on TGO 91 and 92