The difference between GMP and GACP

Good Agricultural and Collection Practices VS Good Manufacturing Practices

The above terms often get thrown around in the cannabis industry’s common parlance, but what do they actually mean?

The two most important documents for GACP vs GMP are:

· WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants and

· PIC/S guide to GMP for medicinal products, specifically Part 1 (Basic Requirements for Medicinal Products) and Annex 7 (Manufacture of Herbal Medicinal Products).

GACP applications in the Cultivation and Production of Medicinal Cannabis

In this instance, cannabis is being grown as a medicinal plant to be used as raw material to generate a concentrated active component. To achieve consistency in your product, there are some several key areas that you need to consider:

1. Identify your site – good site selection minimises the number of pollutants in the surrounding environment (i.e. in the soil, or from neighbours), and should ideally be in a location that has a compatible climate for your desired strains. However, this isn’t always the case, and if you’re working with some troubling elements, it is important to identify them beforehand, so you can design-in some risk-mitigating elements (and they don’t come back to affect your product quality later on). Unique attributes of the site should be factored into your facility design (and also influence your choice of grow method, e.g. indoor, outdoor, greenhouse, etc.).

2. Control your source materials and services – this doesn’t just apply to strain selection (which should include knowledge of the identity, quality and performance of seeds, as well as vetting the vendor to ensure legal purchase, e.g. from hemp farmers. Control over source materials also applies to vendors who provide you with growing mediums, fertilisers, nutrient mixes, etc. There are also security issues to consider if relying on third party vendors to perform particular tasks, e.g. transport products, or pick up waste for destruction.

3. Standardise your processes and methods – here is where your Standard Operating Procedures can come into play. Consistency is key and in order to generate a harvest that has reliable levels of active ingredients, all aspects of cultivation should be considered, e.g. frequency of feed, light intensity, cleaning regimes, humidity control, pest management systems, monitoring environmental conditions, harvest methods, plant material quality checks, drying conditions, etc. Record keeping requirements should also be established and internal audits performed to verify the quantities of critical materials on site.

4. Manage personnel and visitors – the number one source of contamination in multiple industries is, and will always be, personnel. Considerations should be made for standardising your gowning and hygiene requirements to minimise the chances of microbiological outbreaks which are time consuming and costly to get back under control.

5. Ensure equipment is fit for use – as with personnel, poorly maintained equipment can also be a big source of contamination, especially if not regularly maintained, cleaned or stored in pest-free locations.

2. The Transition between GACP vs GMP

PIC/S Annex 7 details the transition from GACP vs GMP as the table below:

* Manufacturers should ensure that these steps are carried out in accordance with the marketing authorisation/registration. For those initial steps that take place in the field, as justified in the marketing authorisation/registration, the standards of Good Agricultural and Collection Practice for starting materials of herbal origin (GACP) is applicable. GMP is applicable to further cutting and drying steps.

** Regarding the expression from plants and distillation, if it is necessary for these activities to be an integral part of harvesting to maintain the quality of the product within the approved specifications, it is acceptable that they are performed in the field, provided that the cultivation is in compliance with GACP. These circumstances should be regarded as exceptional and justified in the relevant marketing authorisation/ registration documentation. For activities carried out in the field, appropriate documentation, control, and validation according to the GMP principles should be assured. Regulatory authorities may carry out GMP inspections of these activities in order to assess compliance.

What does the above mean?

Basically, after you generate raw material (i.e. dried plant matter for further processing, or initial crude extracts of resin), any processing after that is considered within the jurisdiction of GMP and crosses over into the Pharmaceutical realm. At this point, the WHO’s “recommendations” turn into GMP responsibilities:

The Similarities and Differences between GACP vs GMP

Looking at the previous list, you might think there may be some space for overlap between the two, and you'd be correct. However, as with all regulations, the devil is in the detail: the GACP “shoulds” often turn into GMP “musts”:

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