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.
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.