Quality assurance is one subject that is unclear to many organizations who are applying to become Licensed Producers, whether they are start-ups just getting into the medicinal cannabis industry or seasoned producers under the MMAR program who are transitioning to the new MMPR program. The goal of this article is to provide information on quality assurance as it relates to the requirements of Health Canada’s MMPR, specifically, the Quality Assurance Person, Section 10 of the Licensed Producer (LP) application, and Standard Operating Procedures and record keeping. The information presented here has not been vetted or endorsed by Health Canada and is provided to the best of the author’s knowledge based on experience consulting for LP applicants. In this article, Health Canada’s terminology is used to refer to the vegetative organs of the cannabis plant as ‘cannabis’ and the floral bud organ that is dried and shipped as product to patients as ‘marihuana’.
Quality Assurance Person (QAP). Each applicant for a producer’s license must identify a qualified individual or persons who will act as the organization’s Quality Assurance Person(s). As of May 2014, Health Canada has specified that one QAP may only fulfill this role for one production or distribution site. This means that even if one medicinal marihuana company plans to produce and/or distribute marihuana on multiple sites, it must employ a QAP for each site and each QAP may only be responsible for that one site. It seems that Health Canada is currently accepting both full-time and reasonable part-time QAPs, as long as each QAP is only designated as responsible for one site. Further, Health Canada is supportive of third-party quality assurance inspections but each QAP employed by a company must be responsible for compliance with the MMPR Division 4, not the third-party service provider.
The QAP is solely responsible for compliance of the LP with all Sections specified in the MMPR Division 4. These duties include:
- environmental surveillance and hygiene control;
- inspecting production resources, packaging material and medicinal material, and issuing inspection reports;
- developing training programs and supervising their implementation;
- preparing and managing quality control documentation and managing all forms of original records concerning production, packaging, sanitation, and inspection; and
- conducting product recalls as necessary, including informing the Minister of a recall and the reason(s) for it.
Section 60.1.a.ii of the MMPR states that each LP must employ a QAP who has the training, experience, and technical knowledge relating to the activity conducted and the requirements of Division 4. LP applicants need to demonstrate that their QAP candidate has relevant experience in addition to knowledge and training, meaning that recent university or technical degree holders will not likely be qualified. Acceptable credentials for QAP candidates that are consistent with Section 60.1.a.ii have not been specified by Health Canada; however, LP applicants should view this as an opportunity rather than obfuscation.
There are key competencies that the LP applicant must demonstrate that its QAP candidate possesses. These competencies can be rooted in a number of relevant professions and industry sectors. For example, it is critical that there is clear evidence that the QAP candidate is able to validate analytical chemistry methods (MMPR Section 53.2) and interpret the data (MMPR Sections 53.1 and 54). Evidence can be in the form of analytical chemistry laboratory courses and related work experience, journal publications, technical reports, and patents. Qualified individuals may include but are not limited to chemists or biochemists with backgrounds in plant, agriculture, food, and pharmacy sciences as well as quality assurance professionals from related fields. Previous experience in cannabis cultivation is not by itself sufficient qualification.
The LP applicant must also demonstrate that its QAP candidate has sufficient knowledge, training, and experience in good production practices (GPP) and/or good manufacturing practices (GMP). Other professional certification such as hazard analysis and critical control points (HACCP) may be beneficial towards qualification. Based on the breadth of approved QAPs to date, it is evident that subject matter expertise in horticulture, natural health products, food production, and/or pharmaceuticals is sufficient qualification.
When preparing his/her resume and supplemental credential information for Health Canada to evaluate, it is advisable that the QAP candidate is directed to include keywords consistent with language in the MMPR Division 4. Keywords may assist Health Canada reviewers to perform their evaluations, particularly in cases in which LP applicants are asked by Health Canada to provide more specific details on their QAP candidate’s qualifications.
Quality Assurance Pre-Licensing Report (LP application form, Section 10). Health Canada states on their MMPR website that cannabis is not an approved drug, medicine, or therapeutic product. The Canadian Consortium for the Investigation of Cannabinoids (CCIC) stated on their website in February 2013 that:
“Cannabis, as a raw herbal product, does not fit any standard regulatory framework, and, in the absence of large-scale trials and major industry sponsorship, is unlikely to ever follow standard pharmaceutical drug development paradigms. The status of herbal cannabis as a controlled substance restricts it from being handled as a natural health product.”.
Within this context, LP applicants should recognize that the language contained in the MMPR is closely aligned with the GMP Guidance Document – Natural Health Products Directorate published by Health Canada in 2006. While the MMPR Division 4 should be adhered to in preparing the QA Pre-licensing Report, LP applicants may wish to review this GMP Guidance Document both in writing the Report and preparing for on-site inspections by Health Canada. The GMP Guidance Document is available on Health Canada’s website.
Health Canada has developed an efficient tiered review process for LP applications. Health Canada must process a large volume of applications weekly, so each LP applicant is encouraged to prepare their materials so as best to facilitate the work of the Health Canada reviewers. Each of the Sections in Division 4 should be addressed in the QA Pre-licensing Report. No matter how the Report is structured, individual Section numbers referenced in Division 4 should be marked clearly (e.g., boldface, underlined). It is advisable that LP applicants do not merely state that they will comply with each of the Sections of Division 4, essentially just parroting Division 4 back to Health Canada in the Report. Practices specific to the applicant’s planned medicinal marihuana production and/or distribution operations and sanitation should be explained for Health Canada wherever possible in the Report, respective to the individual Sections in Division 4. If the LP applicant plans to use third-party resources such as specific software or HVAC maintenance providers, these should be indicated in the Report. Sections 64 through 68 of Division 5 of the MMPR deal with package labeling. Although the QA Person and the QA Pre-licensing Report are only required to address Division 4, the LP applicant may wish to include information on packaging in its Report, since the QA Person needs to demonstrate an understanding of the required label contents.
Standard Operating Procedures (SOPs) and Record Keeping. Comprehensive documented SOPs prepared in conjunction with rigorous staff training and monitoring are cornerstones of a successful medicinal marihuana business. SOPs are established to ensure that processes are clearly defined and carried out in the same manner by different employees. SOPs need to be written and stored as ‘live’ documents for every single aspect of an LP’s operations and sanitation, right down to changing light bulbs and taking breaks to use the washroom. If the LP has its own analytical laboratory, detailed SOPs need to be prepared for all aspects of the lab’s operations and sanitation, not limited to the wet lab protocols.
A good time to prepare SOPs is while security clearance checks are being conducted. This way, the applicant is far enough along in the process to have gained confidence for success in being awarded a producer’s license but it is early enough so as not to leave the applicant in a scramble to quickly prepare SOPs once Health Canada requests them prior to scheduling an inspection. Quick internet searches for SOP templates will reveal several acceptable formats. All SOPs need to be individually coded. SOP formats tend to include statements of purpose and scope, cross-reference to the regulatory document and Section addressed by the SOP, and lists of materials and responsibilities. SOPs must also contain a section in which revisions to the SOP are recorded including reference to a supplementary SOP if one is created. Once the company is operational, employees must document their work by signing on individual SOPs which can be formatted as control forms. It is good record keeping practice to have those control forms signed by the employees also countersigned by the QA Person following his/her inspections.
If one considers the number of SOPs and the number of associated control forms generated by employees each week, the amount of paperwork required becomes staggering. While it is good practice to maintain hardcopy volumes of the company’s SOPs, implementing electronic record keeping practices is highly recommended. Commercial software is available that allows employees to document their work daily using dropdown menus via, e.g., SOP number, date, and employee name.
The development of an integrated database is further recommended. An integrated database can be used to not only store documentation such as the SOPs and control forms but also monitor environmental conditions in the building as well as track product development from potted cutting through to product shipment and receipt. These types of monitoring and tracking systems allow remote access via the internet and mobile apps, virtually placing the QA Person and Responsible Persons in Charge on-site 24/7. Computer-based monitoring and tracking systems are critical tools for efficient quality management and recall organization.
For experienced cannabis producers, the MMPR and their quality assurance requirements represent a significant paradigm shift in marihuana production, packaging, record keeping, and distribution. As more and more producers are licensed, Canada will emerge as a world leader in safe, quality assured medicinal marihuana which is to the benefit of everyone. This short article has provided an overview of the current status of MMPR quality assurance. If LP applicants require assistance, numerous expert QA consultants are available across Canada, so do not hesitate to get in contact with them in order to clarify and streamline your application process.
-Special to Lift
Authored by Steven Lund, PhD, PMP. President, Herb Assure Consulting Corporation