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Medicinal cannabis manufacture
Technical guidance on the interpretation of the PIC/S Guide to GMP
Administration and verification requirements
For medicinal cannabis with Schedule 8 ingredients (controlled substances) in the Poisons Standard, there are both administration and verification manufacturing requirements.
The Schedule 8 status of some medicinal cannabis puts specific requirements on adequate administration of quantities of cannabis-containing materials that you:
- hold in storage at any particular point in time
- supply (split up in recipients and shipments)
These requirements apply throughout all manufacturing processes, including all handling.
The PIC/S Guide to GMP also includes requirements on recording quantities of materials and the reconciliation of these at the end of manufacture.
When manufacturing medicinal cannabis products, you can use one set of records and documentation that serves both purposes as long as these records comply with the GMP requirements as well as the requirements from the product's Scheduling.
The Schedule 8 status of some medicinal cannabis also requires the manufacturer of medicinal cannabis products to verify that:
- each supplier of medicinal cannabis holds current licence(s) and permit(s) under the Narcotic Drugs Act that allow the supply of each delivery
- each of the customers to which you supply medicinal cannabis hold current licence(s) and permit(s) under the Narcotic Drugs Act that allow them to receive the delivery from you
Both verifications are required for each delivery and for each supplier or customer. The recommended way to meet these requirements is to include verification of:
- your supplier's licence to manufacture narcotic drugs in the supplier qualification process that is required under GMP
- the current status of that licence and the availability of the required narcotic drugs permits in your procedures on incoming goods receipt
- your customer's licence to manufacture narcotic drugs in your regular process to include customers in the customer database
- the current status of that licence and the availability of the required narcotic drugs permits in your procedures on outgoing goods shipment.