What are Good Production Practices for Medical Marijuana?

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What are Good Production Practices for Medical Marijuana?

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

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-use-marijuana/licensed-producers/additional-information-licensed-producers-under-access-cannabis-medical-purposes-regulations.html

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.

Product Quality

Licensed producers must conduct tests on their products, including, as applicable:

  • For microbial and chemical contaminants of fresh and dried marijuana, and cannabis oil
  • Heavy Metals
  • For residues of solvents in cannabis oil for content of delta-9-tetrahydrocannabinol, delta-9-tetrahydrocannabinolic acid, cannabidiol and cannabidiolic acid

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

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-use-marijuana/licensed-producers/guidance-document-technical-specifications-dried-marihuana-medical-purposes.html

Purpose

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.

Background

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.

Procedures

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.

Other requirements for GPP

Licensed producers must also meet other requirements under Good Production Practices under ACMPR including, but not limited to:

  • Sanitation Program
  • Standard Operating Procedures
  • Establishment of a Recall System

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.

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