SELF INSPECTIONS – Keeping the Business Compliant by Implementing Best Practices
Cannabis businesses are subject to many different inspections from regulatory bodies, including the Occupational Safety and Health Administration (OSHA), Environmental Protection Agency (EPA), and Health Canada. Of all the inspections a Licence Holder (LH) will face, Health Canada inspections are critical to the business in terms of being permitted to produce and sell cannabis products as well as to assess and monitor compliance with the Cannabis Act & Regulations.
Interacting with these regulatory bodies is routine, however keeping your business compliant and ready for inspections can be overwhelming. Therefore, the best approach is to conduct self inspections/internal audits on a regular basis to ensure safety, compliance and quality standards are in place, and maintained.
Best practices include forming an internal audit team, with a lead auditor, who together are responsible for proactively assessing and monitoring the compliance of the business with Cannabis Regulations and will verify that all applicable regulations are being followed. It’s good practice to have independence in the audit – i.e: the lead auditor should not be auditing their own activities. Additionally, each functional area should be included in an annual self inspection schedule – to ensure all functions are compliant.
Self Inspection List:
The internal audit team must examine the site documentation and records to verify compliance with the Cannabis Regulations. The following list provides key areas in which an internal auditor should focus on during the assessment.
- Approved Licenced Activities:
The auditor must review the site licence to confirm the activities being conducted by the licence holder correspond to those indicated on the site licence.
- Starter Verification:
Review of documents/electronic records for identification of the legal source from which the licenced holder obtains their starting materials.
- Shipping and Receiving: Records:
Review of shipping and receiving records to ensure safekeeping of substances during transportation, receipt of only approved materials, inventory management principles are followed (such as first-in-first-out) and reconciliation of shipments.
- Standard Operating Procedures:
Confirmation that standard operating procedures (SOPs) as required by the Cannabis Regulations have been established and are followed.
- Good Production Practices:
Verification that the licence holder is meeting the requirements of Good Production Practices (GPP), including use of pest control products, production, packaging and labelling, sanitation program, Standard Operating Procedure (SOPs), list of all brands produced.
- Record Keeping and Reporting:
Verification of record keeping procedures; and verification of reporting methods for loss or theft, adverse reactions, dried marijuana and cannabis oil recalls, and changes of key personnel. Production records for each batch of cannabis propagated, sowed, harvested or dried, the date on which each activity took place, and the total net weight of the substance. Production records for each batch of cannabis oil produced, the date on which the activity took place, and the total net weight of the substance.
- Physical Security:
Verification of the physical security requirements for the site; including secure storage area/room log in/out records, alarms records, visual recordings and other security-related records.
- QA/QC Records:
Review of complaints, adverse reaction records, deviation reports, training records as maintained by the QA department. For QC records this includes product testing and release records, out of specification investigations and method validation status.
- Destruction Records:
Verification of destruction procedures (on-site, off-site). Date of destruction, name of the substance, net weight, location, destruction method, names and qualifications of the witnesses with signed statements and the name of the person who accompanied the cannabis.
- Client Registration Record:
Name of client, healthcare practitioner verification, client’s unique identifier (manner and date it was communicated, copies). Process for transfer of client registration between licence holders should be verified.
- Monthly and Annual Inventory Reports:
Monthly and annual inventory reports submitted to Health Canada must be up to date and accurate. Any discrepancy must be reported and investigated.
- Finished Product Review:
Finished products must be inspected for compliance to the Cannabis Regulations.
This list above is not exhaustive and additional documents will normally be requested based on the facility needs, functional area being audited and any trends that have been noted at the facility.
When resources are limited, outside perspective is sought or when independent auditors are not available (due to lack of training or when the facility is small). A self inspection can also be conducted by third- party experienced auditors. This is advised for new facilities, when the facility is undergoing extreme change or busy periods, or when an additional perspective is desired for process improvement opportunities.
CCI has a team of auditors to facilitate implementation of the internal audit program and help your business identify gaps early on for a successful Health Canada inspection! Contact us today to learn about how we can help.
By: Samina Saeed, CCI Quality and Regulatory Consultant