What is GMP

sea, waves, sand

GMP is shorthand for Good Manufacturing Practices. GMP was developed by the pharmaceutical industry in the past 50 years to recommend guidelines for the production of medicines. It is all about quality, recordkeeping and cleaning. I’ve followed GMP guidelines for my entire pharmaceutical career, producing hundreds of batches of active pharmaceutical ingredients. 

Now, GMP has become a buzzword in the cannabis space. What does this mean, and is true GMP really being practiced?

The GMP guidelines for pharmaceutical ingredients and products were developed by an international organization, the ICH: The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. https://www.ich.org.

The Guidelines are rather specific to synthetic organic drug molecules, substance and product, but we can apply some of the recommendations to hemp/cannabis processing. The relevant part of the ICH guidelines for cannabis is the quality portion, whose recommendations are found here: https://www.ich.org/page/quality-guidelines.

Recordkeeping, cleaning and product segregation are the mainstays of GMP, and the same is true for the interpretation of the guidance as applied to hemp/cannabis. Let’s explore how these three recommendations apply to the cannabis industry.

Recordkeeping: Each batch shall have records of the ingredients used, lot numbers of those ingredients, and a contemporaneous record of all major operations performed on the batch. This data can be stored in a logbook, a batch sheet, or electronically.

Cleaning: Between different lots of starting material, a complete cleaning should be done to the wetted parts of the system. In Practice, this means your equipment must be cleaned between customers. This is especially true when dealing with clients with differing cannabinoid profiles (CBG vs CBD vs THC). Verification of cleaning can be done by visual inspection or preferably, via analysis of a rinse after cleaning. In general, a visual inspection is fine as long the next batch has a similar profile to the previous batch (for example Organic hemp followed by organic hemp). But if you are going from organic to non-organic biomass, or from CBD to THC extraction, then a more robust cleaning verification is warranted.

Product Segregation: All processed lots require a unique lot number, and must be kept separate from other lots. This guidance has less relevance to cannabinoid processing, since we generally deal with one cannabinoid at a time, but each customer should feel confident that their product is not contaminated by the previous customer’s biomass.

At Vermont Organic Science, we practice GMP according to the above guidelines. Remember, these are guidelines, not laws, so interpretation of the recommendations by the producer is key.