MediPharm Labs Adopts A Robust Quality Management Software
MediPharm Labs takes quality assurance seriously. Now, it's tracking it digitally too. The company recently adopted a quality management software platform. By upgrading its paper-based system to a state-of-the-art digital one, the fast-growing cannabis company, with operations in Canada and Australia, further readies itself for scaling up its leading-edge global platform. Here’s how MediPharm Labs did it.
Over the last two years, MediPharm Labs has grown its production capabilities and operations substantially in its expanding facility in Barrie, Ont., plus is ramping up production at a new facility in Wonthaggi near Melbourne, Australia.
The quality management system has always been a priority at the company’s cannabis manufacturing facility, and a paper-based quality assurance system worked successfully since its launch in 2015. Leveraging a well-trained team that was mostly recruited from the pharmaceutical industry, the company has adapted to Health Canada’s evolving regulatory requirements, plus secured good manufacturing practices (GMP) certification.
As a contract manufacturer of white label and private label products for others, MediPharm Labs keeps meticulous records of its operations should these Licensed Producers, CPG clients, Health Canada or other international regulatory bodies ever have queries.
“While a paper-based system was suitable for MediPharm in our initial stages when we were establishing processes, as we grew in terms of manufacturing cadence, the paper-based system became unwieldy,” says Dr. Chris Talpas, Vice President of Quality and Scientific Affairs for MediPharm Labs.
Dr. Chris Talpas, Vice President of Quality and Scientific Affairs for MediPharm Labs.
There was sometimes duplication in change requests and difficulty in tracking if a deviation was a one-time occurrence, or had happened before. Producing documentation for tasks such as quarterly management review was time-consuming.
“While one can be GMP compliant without this software, it does make a world of difference in terms of one's ability to track and maintain GMP compliance,” says Dr. Talpas. Ramping up production at its two facilities, meanwhile, would prove more challenging and time-consuming with the original system.
It was time to go digital to save time and duplication and further ready the company for world markets.
Just under a year ago, the company assessed the quality assurance software offerings on the market. “We wanted a well-established system,” says Dr. Talpas.
Their chosen software satisfied MediPharm Labs’ criteria that it could help the company meet GMP requirements, and also be configured to meet Health’s Canada’s approval structures.
With a tight manufacturing schedule to uphold, the company opted for a three-phase implementation that offered minimal disruption to its manufacturing deadlines.
Over a nine-month period, it onboarded first the document control and change management modules of the system. Then, the deviation and corrective and preventative action (CAPA), and then the training module, which helped with training employees and managing training records.
Dr. Talpas says the company is already seeing the benefits of the new system. Particularly, the change control function allows multiple subject matter experts to see the impact, risk assessments and action items simultaneously, so they can perform their tasks in parallel. Not only do these teams miss nothing with the new system, but they can make changes more efficiently while knowing what everyone else is up to.
The training module, meanwhile, tasks team members with the need to train on new modules as soon as they upload or when the procedures are revised, making sure everyone on site knows how to operate the system, almost in real-time.
The onboarding of the new software has been so successful that Dr. Talpas says the company is assessing possible new modules, including supplier quality management.
As MediPharm Labs keeps growing domestically and internationally, it will do so with its quality processes more than well in hand.
Learn more about MediPharm Labs pharma-quality standards here. https://www.medipharmlabs.com/about-us/our-pharma-quality-standards