By Molecular Science Corp.
If you hang around the cannabis industry long enough, there is a good chance you will hear someone mention the acronym “GMP”. While many are relatively familiar with what GMP means in general, they may be less clear on what it means to be a GMP testing lab operating within the cannabis industry.
Good Manufacturing Practices (GMP) is a system that consists of processes, procedures, and documentation for ensuring that products are produced consistently and according to established and current quality standards. GMP is recognized as a standard for the manufacturing and production of pharmaceuticals, cosmetics, dietary supplements, and food and beverage products in many countries around the world, however, it is often the case that GMPs are modified by local governing bodies to fit the needs of their respective country or geographical area.
Applying this to cannabis, companies that adhere to GMP can have a greater confidence in the consistency and the quality of the products being manufactured in their facilities. For cultivators and processors of cannabis, GMP accreditation requires that a list of quality-related criteria be met and maintained, through implementation of policies and procedures in their facility. Maintenance of GMP accreditation also requires that the accredited business allows the governing body (Health Canada) to perform regular inspections of the business’s internal systems and documentation to ensure they sufficiently meet the minimum criteria for maintaining GMP accreditation.
But what does it mean when an analytical testing lab that provides cannabis testing services holds a GMP accreditation? Great question!
To clarify, for a lab to provide analytical testing services to cannabis cultivators, processors, or sales agencies in Canada, and for those test results to be recognized as valid by Health Canada, a lab must hold an analytical testing license (ATL) for cannabis. However, for an analytical testing lab to claim it is a GMP lab, it must undergo and pass an additional GMP inspection from Health Canada, and successfully receive its Drug Establishment License (DEL).
What value does working with a GMP testing lab provide to cannabis companies?
When you entrust your cannabis testing to a GMP certified lab there are several valuable assurances you can expect that may not always be guaranteed when working with other labs.
Firstly, at the core of a GMP lab is a Quality Management System (QMS). A QMS provides the infrastructure for housing an organization’s policies, processes, documentation and includes the required information on the resources needed to implement and maintain it. Through the development, implementation, and maintenance of a robust QMS, most GMP requirements can be met and maintained.
GMP accreditation requires that a laboratory organization’s QMS includes protocols and procedures for:
- maintenance and calibration of all in-use equipment in the lab, including retention of all supporting documentation
- tracking of all consumables and chemicals required for testing, including careful oversight of expiry dates on perishable materials, as well as storage temperature monitoring of all chemicals that require refrigeration.
- validation of test methods used for generating QC data (according to national standards)
- comprehensive personnel training program
- control of facilities and environmental conditions
- maintaining sample integrity and identification
- ensuring traceability/auditability of all data generated in the lab
- verifying the accuracy of results by Quality Assurance Department
- ensuring all electronic data generated is backed up and maintains its integrity for a specified retention period.
- Quality Assurance oversight on data generation, both electronic and paper, and release of reports to ensure accuracy, objectivity, and impartiality
- internal audits (performed by MSC) and external audits (performed by Health Canada)
Therefore, when working with a GMP testing lab like Molecular Science Corp., you can expect:
- that our lab equipment is maintained and calibrated frequently and according to the equipment vendor’s recommendations – we can show you the documentation!
- the chemicals and consumables used for testing are not expired or degraded beyond limits deemed acceptable by the supplier, and that our chemicals were stored in acceptable environmental conditions while in the lab – very important for the accuracy and reliability of analytical testing!
- the systems and test methods we use for generating QC data are validated for use in a GMP environment – want to see how each validation was performed? Just ask!
- We are audited internally by ourselves to ensure ongoing adherence to policies and procedures that are in place. As well, we are inspected by Health Canada to ensure our policies and procedures adhere to the requirements of GMP guidelines . Don’t just take our word for it – you can check here.
- all data generated within our lab is fully auditable in the case that an investigation is required – we hope this is not the case for our clients, but if and when it is we have you covered!
- the data generated in our lab is fully backed up and recoverable in a way that maintains the integrity of the original data – even if our building burned down, we can recover your data!
It should be made clear that some non-GMP labs may adhere to most or even all requirements related to GMP accreditation, however it is not guaranteed.
GMP is not a requirement for providing compliant analytical testing services to cultivators, processors, and sales agencies in Canada, however GMP accreditation provides additional assurance that your lab partner maintains rigorous control over the processes and procedures that ultimately ensure that accuracy and reliability of your analytical testing data and final test results.
If you are interested in speaking with someone from Molecular Science Corp. about GMP analytical cannabis testing services, please contact MSC here, or give us a call at 416-800-0479.