SUNLEAF CANNABIS CONSULTING SERVICES 

Sunleaf ​Microcultivation -- Other Services:

Pre-Submission Readiness Assessment

For micro licence applicants, we can review your submission documents and find at least 5 changes that Health Canada is going to ask for and that will thus slow down your application process. (Because HC will take 3 weeks to get back with you and tell you what is needed.) If we don't find at least 5, we give you half your fee back. (Fee: $500)

Pre-Inspection Quality Records Audit

For licencees, this audit will identify weaknesses that will result in regulatory "Observations" during your Health Canada Inspection. Everyone gets Minor Observations, but only 5 Majors are allowed before your site is deemed "Non-Compliant". A rating of "NC" means you cannot sell --or even process-- further product until your site is brought back into compliance. A Non-Complaint rating damages your reputation in the the industry with potential investors and with B2B sales, and can take many months to rectify.

While some HC inspectors are actually inspecting at GACP/GPP Standards, MOST inspections are being conducted in accordance with GMP Standards. For example, Forward-Backward Problem Tracking Traceability is not required of GACP or GPP, but is required by HC. This is a distinctly GMP requirement. Destruction Records need to list the Method of Destruction (MOD) as well as the address/site where the destruction occurred, EVEN IF your SOP clearly states both, or you may end up with a Minor Observation for it, as I did. So, the Pre-Inspection Quality Records Audit is highly worthwhile and can save many months of hassles. (Fee: $600)