Bedrocan develops new practice for cannabis cultivation
Bedrocan has developed a new practice for medicinal cannabis cultivation. The practice is already in use at Bedrocan’s facilities and is called GMCCP: Good Medicinal Cannabis Cultivation Practice. According to Bedrocan, GACP is not sufficient for cannabis intended for medicinal use, hence the need for a special practice for the cultivation of medicinal cannabis.
At the moment, Good Agricultural and Collection Practice (GACP) is the only set of requirements available to companies within the EU for the cultivation of medicinal cannabis. This GMCCP standard exceeds the requirements as defined in GACP. The ultimate purpose is to increase the quality of medicinal cannabis cultivation and to get it as close as possible to GMP, while simultaneously taking into consideration the complexity of cultivating the cannabis plant for medicinal and scientific use.
The introduction of GMCCP has gone smoothly within Bedrocan. Actually, not much has changed because Bedrocan already had strict rules in place for growing cannabis. For example, Bedrocan has a quality management system (QMS) to guarantee product quality and continuous process improvement. It ensures that all cultivation operations are carried out in a correct and consistent manner.
Cannabis cultivation: GMP certificate
Until recently, these stricter cultivation rules were covered by Bedrocan’s GMP certificate, which was obtained in 2017, the first of its kind for a cannabis grower in the world. However, the Dutch inspector then drew a line after the cultivation of plants. Cultivation, including the making of cuttings, the vegetative and generative phase, and the harvest were no longer subject to GMP, but to the less stringent GACP. The reason for this change was that GMP requirements cannot be applied to the cultivation of plants. “Working in cleanrooms is a requirement for GMP, but it is not realistic to grow plants, with all its microorganisms in a GMP cleanroom,” says CEO, Jaap Erkelens, in an explanation. The processing phase, including drying, primary processing, and packaging, remained GMP certified.
GACP is not sufficient
However, growing pharmaceutical grade medicinal cannabis requires a clean and controlled environment. According to Bedrocan, GACP is not sufficient for cannabis intended for medicinal use, especially when inhaled. Erkelens says: “You want to prevent the end product from being contaminated with micro-organisms and other contaminants, such as pesticides that can be harmful to the patient. This is only possible in an environment where everything is checked, validated, and documented.”
Bedrocan, therefore, applies the strictest possible hygiene regulations for cultivation, and checks and validates all steps to ensure that the end product is free of pesticides, molds, and other contaminants. “These are more demanding requirements than those that are defined within the GACP, the practice used by the big majority of other medicinal cannabis growers worldwide. Although GACP is intended for the cultivation of medicinal plants, it allows outdoor cultivation and does not require advanced and high-quality indoor cultivation, which Bedrocan has been applying for years. As a result, the global market is overloaded with cannabis products of questionable quality that often have to be recalled because they are contaminated with pesticides and other types of contaminants”, says Erkelens.
To prevent this contamination, Bedrocan is advocating for a new, better quality practice that applies to the entire sector.
What is the difference between GACP and GMCCP?
The main difference is that GACP leaves far too much room for interpretation. It does mention many things which we also mention in GMCCP but does not clearly state what are the exact requirements and how extensive their implementation must be. In that sense, GMCCP is a much stricter practice because it leaves little to no room for interpretation and flexibility.
| GMCCP | GACP |
|---|---|
| Indoor | Outdoor / Greenhouse |
| GMP QMS | Basic QMS |
| Training performed and documented | Training performed but not necessarily documented |
| Gowning procedure must be established | Workers should wear protective clothing to prevent contact with toxic and potentially allergenic substances |
| Cleaning and sanitation must be recorded, validated, and performed according to established procedures and cleaning schedules | Buildings used in the processing of harvested medicinal plants/herbal substances must be clean |
| Acceptance criteria for residues and the choice of cleaning procedures and cleaning agents also must be defined and justified | n/a |
| Cleaning validation | n/a |
| Validation procedures documented | n/a |
| Calibration of equipment involved in the cultivation process | n/a |
| Critical Quality Attributes and Critical Process Parameters should be identified | n/a |
| Batch Records | n/a |
| Good Documentation Practice | n/a |
| Cultivation process has to be standardised in order to ensure reproducible results | n/a |
| Deviation, CAPA & Change Control | n/a |
| Vendor and Material Qualification | n/a |
| Risk Management | n/a |
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