Achieving a Good Manufacturing Practices (GMP) Certification - MediPharm Labs
How MediPharm Labs, a Canadian extraction-only cannabis company achieved their GMP certification and secured the same for its Australian facility.
Delivering cannabis extracts and formulations to the highest standards of quality and safety takes hard work and planning. Last December, MediPharm Labs’ commitment to these standards got the ultimate nod when it achieved Good Manufacturing Practices (GMP) certification from Australia’s Therapeutics Goods Administration (TGA). And just this month, its Australian production facility secured GMP certification from the TGA as well. GMP opens up international markets to MediPharm Labs, but just as importantly, it acknowledges the care taken in every aspect of a product’s lifecycle including but not limited to manufacturing, testing, product release and distribution.
To gain access to various world markets, companies that make medical-use products often need internationally recognized seals of approval. Specifically, GMP certification opens up the door for MediPharm, which specializes in the manufacture of pharma-quality cannabis products, to become part of international medical cannabis supply chains, and work with pharmacy distribution networks and pharmaceutical companies.
“Having a GMP certified platform and research licence permitting human trials ensures MediPharm Labs can produce and deliver purified, pharmaceutical quality cannabis oil and advanced derivative products to patients and consumers each and every time — building trust and satisfaction,” says Nigel Dewsbury, Head of Quality for MediPharm Labs.
Nigel Dewsbury, Head of Quality for MediPharm Labs
MediPharm Labs’ 70,000 square foot Canadian facility was designed by specialists who serve the pharmaceutical industry, and includes ISO standard-built cleanrooms and critical environment. The team was already running this best-in-class production facility and had received licensing from Health Canada to conduct controlled human sensory trials of a wide range of cannabis products in October 2019.
But the team had a grander vision: to achieve GMP certification. GMP is the world’s gold standard for production excellence. It is a system for ensuring that products are consistently produced and controlled according to pharmaceutical quality standards. It’s meant to reduce risk during pharmaceutical production — after all, human health is at stake.
Good Manufacturing Practices are defined by the Quality Systems that relate to: Premises and Equipment; Personnel; Documentation; Production Systems (Processing and Sanitation); Laboratory Controls; Quality Control; Materials System; Packaging & Labeling System; and the Overall Quality Management System. To qualify for GMP, a range of safety and quality control equipment and procedures pre-requisites need to be in place, including but not limited to a purpose-built facility with clean rooms and critical environments, specialized teams, cleanliness, a secure supply chain, standard operating procedures and testing.
MediPharm Labs’ Barrie facility was more than ready to pass GMP inspections. Since its launch in 2015, the company had been focusing on excellence as it established its production facility using best-in-class equipment, teams and protocols.
“To meet the requirements, a company needs to have a well-designed and correctly implemented quality management system that incorporates good manufacturing practices (GMP) and quality risk management, fully document the pharmaceutical quality system and monitor its effectiveness and make sure your entire pharmaceutical quality system is properly resourced with qualified personnel and suitable/sufficient premises, equipment and facilities,” says Dewsbury.
While receiving a GMP certification at the Canadian facility was an asset for working in Canada, MediPharm Labs’ quality extracts were already doing well on home soil. With a facility in Australia, MPL wanted access to emerging international markets that required the production of pharma-quality cannabis.
Dewsbury and his quality team started preparing Internal processes for the auditor, the Therapeutics Goods Administration (TGA, which is part of the Department of Health of the Australian government, from the start of MediPharm Labs. The equivalent of Health Canada for Australia, this organization had one significant advantage: it is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international body that seeks to harmonize GMP recognition processes worldwide. This 53-member group has representatives from countries around the world. Many PIC/S members, including the TGA, have mutual recognition agreements with other member nations, so their regulatory authorities recognize their granted certifications, including GMP.
Since MediPharm Labs was constructing a facility in Wonthaggi, a seaside town near Melbourne, working with Australia’s regulatory body made perfect sense. The TGA would do an extensive audit of MediPharm’s Canadian facility in Barrie, and ideally, approve it for GMP which would clear the company to manufacture medicine and active pharmaceutical ingredients (API) for the Australian market and beyond.
Dewsbury and staff arranged for an inspection of the Barrie, Canada facility with TGA staff. That happened between October 14 and 16, 2019.
Less than 60 days after the inspection, the TGA granted MediPharm Labs GMP certification.
“I cannot overstate the importance and prestige of earning our first GMP certification,” said Pat McCutcheon, Chief Executive Officer of MediPharm Labs. “GMP certification is the ticket to gaining access to rapidly growing global medical cannabis markets. And it is the recognized standard by which pharmaceutical manufacturers and consumer packaged goods companies worldwide judge their supply partners.”
This allowed the business team at MediPharm to jump-start more international relationships.
The Australian facility wrapped up construction and opened in December 2019. It then put in its application for GMP certification to the TGA. On May 7, 2020, it secured certification, creating a seamless supply chain between Canada and Australia, and furthering the company’s ability to gain credibility in other global markets.
When an organization stays focused and holds to its values, anything is possible. MediPharm Labs holds itself to an exceptionally high standard and counts on each team member to do the same. Because this has been MediPharm Labs’ ethos from the get-go, it was able to achieve GMP certificate in a short order, truly standing out as a global leader in the manufacture of high-quality cannabinoid-based products.