Cannabis manufacturers are required to define their quality management policies and quality control of pharmaceutical manufacturing operations in accordance with local governmental health authorities and laws.

The following process outlines the steps required to create a Site Master File (SMF).

  1. Site information on the manufacturer.
  2. Authorized pharmaceutical manufacturing activities of the site.
  3. Any other manufacturing activities.
  4. The quality management system used by the manufacturer.
  5. Release procedure of finished products.
  6. Management of suppliers and contractors.
  7. Quality risk management (QRM).
  8. Product quality reviews.
  9. Personnel.
  10. Premises.
  11. Equipment.
  12. Documentation system.
  13. Type of products.
  14. Process validation.
  15. Material management and warehousing.
  16. Quality control.
  17. Distribution.
  18. Complaints, product defects, and recalls.
  19. Self-inspections.

Requirements for Australia: