Is your GMP also BMP?



Andrew Heath
Cannabis Products Manager - Novachem

Novachem’s business is concerned with standards. Quality standards for medicinal products are of particular interest. This article concerns Good Manufacturing Practice (GMP) and cannabis materials intended for medical use. 

GMP is an absolute requirement of the quality of all medicines.  Medicine manufacturers need to comply with GMP guidelines to have medicines accepted for patient end use in Australia.

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 permits 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 is seen the same.

Australia’s Therapeutic Goods Administration (TGA) [1] describe 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, GMP PIC/S - the Pharmaceutical Inspection Co-operation Scheme - operates[2] across 54 participating regulatory authorities[3]. 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 is a requirement that products conform to GMP. Indeed, in Australia, GMP certification implies assurance of product quality 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 must 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 product they are supplying.

The reason that 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 first meet GMP only 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 the product after harvesting. However, at that point, the product is essentially complete – at this stage, it is not possible to build in quality to the final product.

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Propagation

Maturation

Flowering

Harvesting

Drying

Primary Processing (trimming etc.)

Milling

Extraction

Refining

Formulating

Filling

Labelling

 

 

 

 

 

 

 

Most Oil GMP

 

 

 

 

Most Flower GMP

 

 

 

GMP Flower

Best Manufacturing Practice (BMP)








A GMP product which is intended to be administered by pulmonary inhalation, ideally should 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 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 tenant of GMP and one to which all products, especially medicinal cannabis products should be held to account.



[1] Therapeutic Goods Administration (TGA) https://www.tga.gov.au/good-manufacturing-practice-overview

[3] PIC/S is an extension to the Pharmaceutical Inspection Convention of 1970