Standard Operation Procedures
Standard Operating Procedures are the foundation of a
reliable and consistent quality control system.
Standard Operating Procedures (SOPs) are the foundation of a reliable and consistent quality system. SOPs are a comprehensive set of documents which clearly define how to complete the process, in a step-by-step manner, as well as who is responsible for the process, what materials are required and how the process is to be documented. When it comes to medical cannabis production, the ACMPR regulations tell you WHAT you need to do, but your SOPs tell you HOW to do it and the associated records within the SOPs provide PROOF that you did it.
SOPs need to be written for every aspect of a medical cannabis business, including operations, production and quality assurance. However, just writing the procedures is not enough. Once written, staff need to be trained on the procedures and monitored to ensure they are following them and doing so correctly. SOPs are constantly changing documents, which require review and revisions as necessary.
There are procedures that Health Canada tends to pay significantly more attention to during the application stages, specifically those pertaining to security, inventory control, and the information contained in Subdivision D of the ACMPR – Good Production Practices. Examples of SOPs that ensure these areas are covered include Facility Security, Inventory Control, Loss and Theft, Facility Sanitation, Equipment Cleaning, Health and Hygiene, Personnel Training, Development and Revision of Standard Operating Procedures, Product Sampling and Testing, Product Release or Rejection, Product Returns, Product Complaints, Adverse Reactions and Product Recall. However, when it comes time for your Pre-Licence Inspection, Health Canada is going to want to see that you have a full set of procedures in place and that staff are fully trained on them.
What is also important to note is that SOPs need to be specific to your operations. Different manufacturing activities (e.g. dried cannabis, cannabis oil extraction, encapsulation), growing methodologies (e.g. hydroponics) as well as facility design (e.g. greenhouse) require different sets of procedures. CCI has experienced consultants in many different aspects of cannabis production who can help to customize your SOPs to your operations, ensuring a consistent quality product for each and every batch.