March 3, 2020 | 1 minute read

What does GMP mean?

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GMP, EU-GMP, cGMP, GACP, "The Orange Guide", the list goes on. What do all these acronyms stand for and what is their use in the medical cannabis industry? The article below provides a solid introduction into the terminology used and why having so many can be problematic.

Good Manufacturing Practices, GMP, is a codified set of rules and regulations that ensure the quality, safety and efficacy of a drug. It covers all aspects of the production process and is audited and certified by regulatory agencies. Put simply, GMP certification is generally a prerequisite to the export of medical cannabis.

In an age of global trade, the importance of having equivalent standards is paramount. A buyer in Australia wants assurances from the seller in the UK that the produce being delivered meets a desirable level of quality, free from contamination and analytically meets the required specifications. Australia and the UK may have almost equivalent guidelines but trade would be greatly facilitated if both followed the exact same rules. Furthermore, with such equivalence, it will be easier to track the provenance of the produce and give comfort to any regulators or consumer watchdogs.

What Do GMP Guidelines Include? These are guidelines, not steps. As a result, from a bird’s eye view, all international and sovereign national GMP standards include a few basic principles no matter how much they may differ in the weeds. Namely: - That manufacturing processes are clean, controlled and processes are verifiable and repeatable. Changes to any and all must also be clearly documented. - Record keeping, accurate accounting (of product and on the financial side) must be kept, including complete batch history through manufacture and distribution to the end user. Audits are a way of life. - Recall procedures must be in effect. - All complaints about products must be examined.