This course is based on the Health Canada Cannabis Regulation and is a complete training solution for all individuals that need to acquire knowledge of regulations to work in the cannabis / Marijuana industry in Canada.

Learning objectives

Upon completion of this online course trainees will:

  • be able to understand the basics of the Cannabis Regulation;
  • have the confidence to outline the main GPP (Good Production Practices) requirements related to premises, storage facilities and personnel;
  • get familiar with the principles of the GPP quality system and quality control and the important procedures when dealing with complaints and recalls

Course content:

  • What is GPP?
  • Why is GPP important?
  • Official GPP Directives.
  • the basic requirements of Good Production Practice.

Cannabis / Marijuana  Quality System

  • Principle and overview of the Pharmaceutical Quality System.
  • Development, content and implementation of PQS.
  • Key personnel.
  • Background and duties of the Qualified person.
  • Duties of the Head of production department.
  • Duties of the Head of quality control.
  • Person releasing the batch.
  • Consultants.
  • Personnel training and hygiene.
  • Production area.
  • Storage area.
  • Quality control areas.
  • Ancillary areas.
  • Equipment.
  • Premises.
  • Generation and control of documentation.
  • Types of documents and specifications.
  • Manufacturing formula and processing instructions.
  • Packaging instructions.
  • Procedures and records.
  • General principles.
  • Prevention of cross-contamination in production.
  • Guidelines for starting materials.
  • Processing operations.
  • Packaging materials and operations.
  • Guidelines for finished products.
  • General principles.
  • Main tasks of the Quality control department.
  • Technical transfer of testing methods.
  • Transfer protocol.

Complaints and Recalls and Reporting of Adverse events

  • GPP Guidelines related to complaints.
  • Classification of defects.
  • Product Recalls.
  • Reporting of Adverse events to Health Canada

This 4-day program covers the first, second, and third party audits as well as Health Canada Inspection of Licensed Producer or Licensed Dealers.  

After Health Canada has conducted their second inspection to grant a license to sell medical cannabis there will be additional inspections that may or may not be announced by Health Canada.  It is important that the site be routinely inspected by a third party to ensure they are on track with GPP and the regulations. Crown College offers its expertise to conduct audits at a very realistic cost. 

Course Content:

Licensed Producer (LP) Application

ACMPR Standard Operating Procedures Technical Writing

As with any operation, Standard Operating Procedures (SOP) must be in place to ensure activities are followed, personnel are qualified and trained, consistency of operations and the quality and security of facilities adhered to.

These SOPs will cover such activities as physical security parameters (from pest control to building security requirements), Quality Assurance Qualifications, testing of products, sanitation program, employee training and hygiene, recall and recall reporting, document control, change control,  labelling and packaging process and control.  These just cover some of the activities required for a compliant and GPP facility as a Licensed Producer.  

Security System Compliance and Design Setup

Every Licensed Producer of Medical Marijuana must have a security system set up.  Given that Medical Marijuana is a narcotic strict control of medical cannabis must be adhered to. In addition building layout and design will tie into this security system.  The regulatory provisions related to the security requirements include:

  1.  Signage and Physical Barriers – eg. fence, signs stating unauthorized access is prohibited
  2. Entrance, Doors and Frames – Fire rated doors, appropriate locks, door closures, switches
  3. Openings, Ducts and Mechanical/Electrical Pass-Throughs
  4. Wall Construction
  5. Glazing Panel Security
  6.  Monitoring and Detection
  7. Video Coverage
  8. Redundancy and Back-ups – all recordings of detected occurrences kept for 2 years and storage of video surveillance  maintained.
  9. Access Control
  10. Security Systems Control Mechanisms – alarm codes, combinations
  11. Intrusion monitoring
  12. Record of Detected Matters
  13. Tampering
  14. Power Supply
  15. Air Filtration

Pre-License Inspection Assistance

Health Canada will conduct two inspections after the License to produce medical marijuana has been issued.  The first inspection will occur after cultivation has begun. This is to ensure that Good Production Practices are followed, the building meets the requirements, personnel are qualified and/or trained among and to ensure the quality of production.  The second inspection would occur prior to selling. This will cover other aspects of GPP including storing, packaging, shipping, record keeping and complete control through this process.

Routine Site Inspection

After Health Canada has conducted their second inspection to grant a license to sell medical cannabis there will be additional inspections (some that will not be pre-announced by Health Canada).  It is important that the site be routinely inspected by a third party to ensure they are on track with GPP and the regulations.