Medicinal cannabis producer Bedrocan International announced this week that its facilities in The Netherlands have been found to be compliant with good manufacturing practice (GMP) standards, following an inspection from the Dutch Health Care Inspectorate.
The site is one of five facilities worldwide which produce marijuana for Bedrocan and its licensees, and the news it has been deemed to comply with GMP standards was described as “significant” by the firm.
“It’s in our mission and vision to bring medicinal cannabis to the level of an evidence based medicine. Being compliant to GMP-standards is one major step in this process,” a Bedrocan spokesperson told in-Pharmatechnologist.com.
The certification represents the first time GMP-status has been given to a site for focusing on cultivation, but with standardised medical cannabis grown indoors and controlled by qualified personnel and high tech equipment, the site fulfils regulatory requirements.
“The European Medicines Agency (EMA) states that GMP is ‘that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use,’ the firm said.
“This means – amongst others – having a clean and hygienic manufacturing area, clearly defined and controlled environmental conditions, validated processes, well-documented procedures and instructions, records of manufacture and appropriate measures in case of defaults or complaints.”
The accreditation covers three facilities in The Netherlands with a total production area of 120,000 sq ft which annually, the firm told us, produce around 5,000kg of cannabis.
The company also hopes its sites in Canada and the Czech Republic will become fully compliant within the next year.
The firm supplies the Dutch Office for Medicinal Cannabis , and some Dutch compound pharmacies in the Netherlands, but also has contracts with pharma companies which use marijuana as an API, including Axim Biotechnologies.
Axim has an ongoing Phase II trial in The Netherlands for its cannabinoid (CBD) and tetrahydrocannabinol (THC) as a possible treatment for multiple sclerosis. It has also begun recruiting for a 40-patient clinical trial for another cannabinoid chewing gum – CanChewPlus – as a potential treatment for irritable bowel syndrome.