The Case for Quality in the New Frontier of Commercial Marijuana
The future is looking bright for the commercial marijuana industry. The Herald is full of stories about people who are now set for retirement after investing in marijuana producers at just the right time. Demand for medicinal marijuana is increasing at 10% per month. Not to mention the impending explosion of recreational pot smokers, estimated to be between 3.5 to 5 million people, once it is legalized by the Liberals. Just 3 weeks ago at the swanky Le Germain hotel in downtown Calgary, cannabis company execs lined up to pitch their companies to investors in a 5-hour rapid-fire conference hosted by Dundee Capital Partner (Dundee's Dragon's Den for Doobies). Even Brett Wilson, Calgary's favourite Dragon, has thrown $3 million into Tokyo Smoke.
Also in the Post last month, there was an article about a marijuana recall initiated by Organigram and Alberta's Aurora Cannabis. Upon reading it, I thought "well, this must be a first for quality control". But a quick search on the Health Canada recall website turned up another 6 marijuana recalls that have occurred since March 2012. Which led me to wonder what kind of controls are in place for the quality of Canada's pot?
Registered marijuana producers must comply with the ACMPR regulations, a vast and comprehensive set of requirements imposed by Health Canada. In fact, you can take a 4-day course on it from AASP, taught by the aptly-named Ms. Bighash. Some other Health Canada regulations that may apply include:
Good Manufacturing Practices Guidelines: GUI-0001
Cleaning Validation Guidelines: GUI-0028
Good Manufacturing Practices for Active Pharmaceutical Ingredients: GUI-0104
Validation Guidelines for Pharmaceutical Dosage Forms: GUI-0029
Good Pharmacovigilence Practices (GVP) Guidelines: GUI-0102
Good Manufacturing Practices for Natural and Non-prescription Health Products
The Canadian Food and Drug Act and Regulations
The Canadian Natural and Non-presciption health Products Directorate
Other regulations include:
ICH Good Manufacturing Practices for Active Pharmaceutical Ingredients: Q7
ICH Pharmaceutical Quality System: Q10
ICH Development and Manufacturing of Drug Substances: Q11
Canadian Fertilizers Act and Regulation
European Pharmacopeia 9th edition
USP (1079) - Good Storage and Distribution Practices
USP (1197) - Good Distribution Practices for Pharmaceutical Excipients
USP (1083) - Good Distribution Practices
WHO Quality Control Methods for Herbal Materials
Sorting through this exhaustive list of requirements and managing their application is a daunting task, and yet critical to establishing a safe, high-quality product supply. A generic Quality Management System framework such as ISO 9001 could go a long way to assisting these producers in identifying quality requirements and applying them efficiently to their manufacturing practices.