The road to GMP (Good Manufacturing Practices) certification is a demanding one, filled with incredibly detailed tasks and tight collaboration by teams across all departments. Over the past three years, JMCC has been quietly building a pharmaceutical quality system (PQS) that encompasses not only EU GMP, but also paves the way for achieving our Good Agricultural and Collection Practices (GACP), ISO 9001 and Good Distribution Practices (GDP) certifications. We are pleased to report we are almost there.
What is EU GMP?
GMP is the globally recognized standard governing the design, monitoring and controls within a medicinal product manufacturing facility. Attaining GMP certification is the highest recognition of production quality, consistency and safety available to companies in the pharmaceutical industry. While many countries accept less stringent standards or use their own version of GMP (such as Canada’s Good Production Practices), the European Union’s GMP is considered the most exacting. Manufacturers producing medicine of any kind for the European market – including medical cannabis – must be certified to EU GMP standards.
To explain it simply, GMP requires:
Identifying and documenting (via Standard Operating Procedures or SOPs, and Work Instructions etc.) the optimal method for performing each key process or work activity;
Refining each process by identifying and documenting the different sub-processes that support the main activities;
Implementing a risk-based approach throughout the quality system;
Validating each process and all equipment to ensure it is fit for the intended purpose;
Ensuring appropriate reporting channels are in place and each process is owned by the respective manager;
Training all employees in the processes specific to their roles and functions.
As JMCC's Quality & Training Manager, Yvette Bryan, explains, the goal is to “document what we are doing, do what we have documented and have the evidence to prove it was done.”
Guided by Yvette and her Quality & Training colleagues, each operations team has undertaken a tremendous amount of work to date. A key output is hundreds of pages of administrative and production site documents that detail every process that happens throughout the production, testing, labelling and packaging of JMCC’s medical cannabis products, from building and facilities design right down to and including facility and equipment cleaning and maintenance, employee hygiene protocols and a detailed vendor assurance program. A suite of training programs for each operations team has also been developed.
All of this work is to prepare for a GMP inspection of JMCC’s facilities by a third-party, EU-certified inspector, the successful completion of which will provide us with the ability to supply medical cannabis in the EU. While international GMP inspections have largely been put on hold by the pandemic, EU regulatory authorities have permitted virtual inspections in that region and are discussing how to extend these to other countries in the near future. JMCC hopes to schedule our inspection early in Q2 this year.
Challenges and Opportunities
Not even a great plan comes off without a hitch, and the COVID-19 pandemic has been our biggest challenge to date. The pandemic derailed timelines, separated team members and created other challenges no one could have foreseen. But it has also created opportunities that we would not have had otherwise.
For example, while some of our executive team, who had previously spent the best part of each month on-site in Jamaica (including COO Chris Simpson, and Business Operations Manager Josh Casson), have been grounded at home in the United Kingdom, our resident operations and quality teams took on the challenge of managing much of the GMP project themselves, dramatically improving inter-team communication and collaboration.
According to Josh, “the JMCC team has stepped up beyond belief.” Each challenge they faced was taken as an opportunity to problem-solve and hone other important skills that may not otherwise have been needed to the same extent. “It’s really been inspiring to see.”
Ensuring product quality and patient safety are the key reasons for pursuing – and attaining – GMP certification. But JMCC has learned that the “side benefits” – including employee up-skilling, improved teamwork and enhanced enterprise-wide communication, make the formidable amount of work involved more than worthwhile.
Investing so much in its PQS and the development of a “quality-rich” culture are solid proofs of JMCC’s commitment to achieving – and even exceeding -- global benchmarks like GMP throughout the organization. And, for JMCC, achieving GMP also means delivering consistent, high-quality medicine for patients, access to international markets and another competitive edge as our business continues to grow.