We are excited to inform you that we received occupancy of our manufacturing facility in Burlington on January 29, 2020. We now have a state-of-the-art pharmaceutical facility that will meet all the rigorous GMP requirements of Health Canada, FDA and EU. As Aubrey indicated in his Chairman’s letter “EmpowerPharm is not a manufacturer of recreational CBD, we’re a Rx CBD company that is 100% pharmaceutical, full stop! A new sector in the pharmaceutical industry…” With a team that collectively has over 300 years experience in the pharmaceutical industry and a state-of-the-art facility, we are ready to embark on the next phase of our evolution. This article will introduce you to the difference between GMP and GPP.
President & Co-Founder
Good Manufacturing Practices (GMP) for Drugs as the Highest Quality Standards for Therapeutic Products
Good Manufacturing Practices (GMP) for drugs is the part of Quality Assurance that ensures that drugs are consistently produced and controlled in such a way as to meet quality standards appropriate to their intended use, as required by the market authorization. GMP guidelines of the Food and Drug Regulations identify critical control points in production and create a system that proactively controls the consistency, safety and purity of the product. Formalized risk assessment and hazard analysis are integral parts of a quality-assurance system designed and implemented on GMP principles. Implementing and complying with GMP principles are expensive, time consuming and require tremendous skills and expertise. It has been widely considered that only companies with extensive financial and technical resources can reach this highest standard of quality, recognized by national regulatory agencies such as Health Canada and FDA, through well established and regular audit procedures.
GMP goes far beyond other less rigorous production practices, such as Good Production Practices (GPP) required by the Cannabis Act from Licensed Producers (LP) of cannabis products. GMP compliance, when compared to GPP, needs to meet a number of additional requirements, such as extensive validation of manufacturing procedures and analytical methods, a well established stability program to support expiry dating, a well defined sanitation program and environmental monitoring, systemic documentation and record keeping procedures to assure data traceability and integrity, and special facility design to ensure direct material and personnel flow to avoid potential cross contamination.
The commercial value and benefits of implementing and maintaining GMP is well recognized even in operational set-ups where GPP is adequate as per the Cannabis Act. Hence, more and more Licensed Producers also strive to achieve the highly coveted GMP status in spite of the often-overwhelming additional cost for adequate facility, extensive testing, complex systems and highly skilled labour.
Tamas Szederkenyi, Chief Science and Quality Officer