Welcome to our summer series on cannabis and GMP/GACP. A new article will be published once a week throughout the summer. You can access related articles that have been published so far by clicking the Compliance category on the main News & Events index page: Compliance category
Cannabis Around the World
The legality of cannabis varies from around the world. In some regions, cannabis is licensed for both medical and recreational use. In others, cannabis is licensed for medical use only. And in some, cannabis remains a prohibited substance for any use.
At the time of writing this, 50 nations had legalized cannabis nationally or regionally for medical or recreational use. Each individual region sets the standards for cannabis production, manufacturing and distribution.
The types of standards that are applied to cannabis are collectively known as ‘quality systems.’ Most quality systems are similar to each other, using accepted good practices. What differs are the processes they cover, which are dependent on the products being manufactured.
In many cases, the standards applied to cannabis are based on pre-existing quality systems designed for other types of manufacturing or production. Since the plants are grown in an agricultural setting, agricultural standards, such a Good Agricultural & Collection Practice (GACP), can be applied. As cannabis has drug qualities and therapeutic value, pharmaceutical standards, such as Good Manufacturing Practice (GMP), can be applied. With testing for THC and other values, clinical or laboratory standards can be applied. As well, general business standards, such as those from the International Organization for Standardization (ISO), can also be applied.
New standards, however, can be created at any time. When Canada was legalizing cannabis, Health Canada created a new quality system designed specifically for cannabis called Good Production Practice (GPP).
When other regions were considering cannabis, however, most decided not to create a new standard as Canada did and chose GMP or GACP instead.
Each of these quality systems has the same type of framework. Rather than rigid rules, most standards provide guidelines for carrying out operations. The standards are not designed to limit how a business operates. Instead, they are intended to guide the facility toward good practices. The ‘how’ of complying is left up to the individual organization. Each facility is allowed to determine the best way to meet the criteria. The final result is what is important.
Quality Standards Benefits
Besides meeting compliance regulations, adhering to a quality system offers many benefits, including increased productivity, improved employee safety, and enhanced customer satisfaction. But one of the main purposes of standards in relation to cannabis is to minimize the following risks.
- Contamination of products that could make them unsafe.
- Inaccurate labelling that could lead to accidental misuse.
- Insufficient active ingredients that could affect efficacy.
- Excess active ingredients that could be hazardous.
These risks are the reason cannabis operations must comply with a quality system, regardless of where they are in the world. There may be one governing body with one set of standards clearly laid out. In other cases, there may be several sets of standards that focus on different areas of operation. When setting up a facility, each cannabis business must identify which standards will apply and how to meet them.
Links
Following are links to the various standards that could be applied to cannabis.
Good Agricultural & Collection Practices/GACP (also called GAP): International; Israel
https://www.who.int/publications/i/item/9241546271
https://www.gov.il/en/departments/topics/medical-cannabis/govil-landing-page
Good Production Practices GPP: Canada
Good Manufacturing Practices/GMP: International; European Union; Australia
Current Good Production Practices/cGMP: USA
Good Distribution Practices/GDP: United Kingdom
https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice