In Canada authorized licensed producers (LPs) for medical marijuana are required by law to meet strict Quality requirements under the Access to Cannabis for Medical Purposes Regulations (ACMPR). One of the main requirements is to comply with Good Production Practices (GPP) in order to produce and sell cannabis to eligible people who wish to have access to cannabis for medical purposes. Good Production Practices, also known as Good Manufacturing Practices (GMP), are part of the quality assurance that ensures cannabis is consistently produced and controlled in such a manner as to meet the quality standards appropriate to their intended use.
Good Production Practices under the ACMPR
Licensed producers are subject to Good Production Practices that are meant, among other things, to ensure the cleanliness of the premises and equipment. The licensed producer is required to employ a quality assurance person with appropriate training, experience, and technical knowledge to approve the quality of fresh and dried marijuana, marijuana plants and seeds, and cannabis oil prior to making it available for sale.
Licensed producers must conduct tests on their products, including, as applicable:
The Technical Specifications for Testing Dried Marihuana for Medical Purposes guidance document provides specific information for licensed producers to help them meet these requirements.
Guidance Document for Technical Specifications for Testing Dried Marihuana for Medical Purposes
The guidance document for Technical Specifications for Testing Dried Marihuana for Medical Purposes is intended to help Licensed Producers (LPs) comply with certain quality requirements in SUBDIVISION D Good Production Practices
Access to Cannabis for Medical Purposes Regulations
Health Canada’s Office of Controlled Substances is the authority responsible for licensing and compliance monitoring under the Controlled Drugs and Substances Act (CDSA) and ACMPR.
DIVISION 1 SUBDIVISION D of the ACMPR includes Good Production Practices requirements relating to the premises, storage of dried marihuana, equipment, the sanitation program, standard operating procedures, recall of product, and quality assurance personnel. Additionally, the ACMPR provide compliance and enforcement measures, allowing for refusal, suspension or revocation of a producer’s licence on the basis of risks to public health, safety or security.
In order to achieve purity and quality of the finished dried marihuana product, Good Production Practices as outlined in the ACMPR must be followed at all stages of production, packaging, labelling and storage of the marihuana.
As specified in the ACMPR, each batch or lot of dried marihuana must be approved for release by the LP’s Quality Assurance person, who must have the training, experience and technical knowledge relating to the activity conducted and the requirements of DIVISION 1 SUBDIVISION D ACMPR. This means that the Quality Assurance person must have the ability to evaluate the operations of the LP to ensure compliance with SUBDIVISION D , and the technical knowledge to be able to assess analytical testing results in order to be able to make the determination of whether the marihuana product is suitable for sale. The Quality Assurance person is also responsible for investigating quality-related complaints and taking corrective and preventive actions, if necessary.
Visual inspection should confirm the absence of pests or extraneous substances. There is no requirement to mill or irradiate the dried marihuana, although LPs may choose to do so.
Licensed producers must also meet other requirements under Good Production Practices under ACMPR including, but not limited to:
Information on Good Production Practices can be found under Subdivision D of the ACMPR (http://laws.justice.gc.ca/eng/regulations/SOR-2016-230/page-8.html#docCont).
PipeDreemz Inc. ACMPR consultants have the expertise in GPP/GMP to make sure that your medical marijuana business follows the requirements under the ACMPR. They will assist you with GMP guidelines under the Access to Cannabis for Medical Purposes Regulations as well as a series of other related documents. Contact Us for more information.