At a time when the TGA is scrutinising the industry like never before, simply saying your product is produced to GMP guidelines is not enough. Novachem cannabis products manager Andrew Heath explains.
Good Manufacturing Practice (GMP) is an absolute requirement for all medicines. Australian medicine manufacturers, including those making cannabis products, need to comply with GMP guidelines to have them accepted for patient end use in this country.
The Therapeutic Goods Administration’s upcoming changes in GMP expectations for imported medicinal cannabis products have shone a spotlight on the different levels of GMP applied to products in local and overseas markets, highlighting a need to know more about quality provenance and processes.
For cannabis medicines, batch-to-batch consistency in chemical constituents (cannabinoids and terpenes) is important for doctors and patients to achieve reliable, repeatable dosing. It enables research with verifiable findings for clinical trials. For manufacturers of oral and inhalation dosage forms, fully GMP-certified active pharmaceutical ingredients guarantee seamless GMP manufacturing.
Currently, not all GMP standards are applied in the same way internationally. The TGA is looking to increase its scrutiny of imported products to ensure there is a level playing field in Australia for local manufacturers. Even then, however, not all GMP is the same.
The TGA describes GMP as a set of principles and procedures that, when followed, helps ensure that therapeutic goods are of high quality.
A basic tenet of GMP is that:
- Quality cannot be tested into a batch of product.
- Quality must be built into each batch of product during all stages of the manufacturing process.
Since 1995, the Pharmaceutical Inspection Co-operation Scheme (GMP PIC/S), an extension to the Pharmaceutical Inspection Convention of 1970, has operated across 54 participating regulatory authorities. The scheme aims to harmonise GMP inspection procedures globally through a framework of training, guidance and standards which represent the foundation of medicine quality.
For cannabis medicines, it needs to be a requirement that products conform to GMP standards. Indeed, in Australia, GMP certification implies product quality assurance and provenance for doctors and patients. However, the stage at which GMP is applied to the product of manufacture is varied.
Simply saying “this is produced to GMP guidelines” is not sufficient. Distributors of cannabis medicines and the regulator must fully scrutinise GMP status to determine the level of GMP which has been applied and at which stage. Practitioners likewise should understand the full provenance of the product they are supplying.
The reason this is so important is that GMP for most cannabis products in the market currently starts well down the cycle of production. Indeed, it is common for cannabis products to meet GMP at the extraction stage of the process where an oil-based product is concerned.
For flower or flos-based products, which are administered directly through inhalation, the process may start when trimming after harvesting. However, at that point, it is essentially complete — it is not possible at this stage to build in quality.
A GMP product which is intended to be administered by pulmonary inhalation should ideally include the process from drying to packaging as the only sure way to ensure batch-to-batch quality is built into the finished product.
Cultivation standards, beyond Good Agricultural and Cultivation Practice and approaching GMP, guarantee no pesticides are used, no fungicides are required, and no heavy metals will ever make it into the plant. Published batch release Certificates of Analysis for starting material showcase quality-related information for transparency and scrutiny. Many cannabis products currently on the market in Australia do not display provenance information or provide release certificates publicly.
Only when you have the full production cycle certified under GMP can you get Best Manufacturing Practice — BMP. GMP, when applied to the entire production cycle of a medicine, is the only way to ensure quality is built into each batch of product.
This is a basic and fundamental tenet of GMP and one to which all products — especially medicinal cannabis — should be held to account, regardless of origin.
- Andrew Heath is the cannabis products manager at Novachem, responsible for certified reference materials used in cannabis testing, medicinal cannabis products import and regulatory compliance.