An “audit” involves taking an outside perspective on how well the day-to-day operations comply with the desired regulations or standards.
In a way, it is similar to doing a home inspection prior to purchasing a home – verifying that what you see is what you get. With regards to facility operations, the ultimate benefit of a third-party audit is for the management team (and shareholders) to gain confidence in their team. Internal (self-audits) are always helpful for routine maintenance, but an outside audit by Cannabis Compliance Inc. brings current best-in-class practices with a fresh perspective, reducing the risk of internal standards slipping below competitor practices.
Audits are an integral part of the licensing and ongoing regulatory compliance process. These audits are rigorous and lengthy and can be a daunting experience for an auditee. There are different types of audits that we offer, depending on the licensing stage, as well as depending on the specific goals. Note that Health Canada will conduct regular audits of a facility, but they will often choose specific items to verify rather than a full audit of the critical compliance areas. Also note that a third-party audit by Cannabis Compliance Inc. will reduce the number of observations with a Health Canada audit if errors are caught and corrected.
Prior to issuing a licence (e.g., Standard Cultivation, Standard Processor), Health Canada may schedule a pre-licence inspection, which focuses on the applicant’s compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, record keeping and good production practices. Licence applicants are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their federal licence.
Health Canada schedules an introductory audit after the pre-licensing audit, when the licensee is ready to start cultivation. Cannabis Compliance Inc. is often hired to participate in and support our clients before, during and after the Health Canada introductory audit. This audit is conducted to verify compliance against regulations (as in the pre-licensing audit) in addition to inventory control/activities being carried out against those indicated on the licence.
Health Canada conducts a pre-sales audit after packaging product that is intended for sale. Verification of compliance to the regulations with focus on packaging, labelling, shipping and testing is the objective of this audit. This audit is the last hurdle before the product can be released for sale to the Canadian market.
cGMP Audit (GUI-0104)
This type of audit assesses compliance against Health Canada’s Good Manufacturing Practices (cGMP) guidelines against Active Pharmaceutical Ingredients (API). Cannabis Compliance Inc. experts have extensive experience with Health Canada audits and conduct mock audits to assist cultivators and processors ahead of the audits to identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.
cGMP Audits for the EU (Eudralex)
Exports to European Union (EU) markets require compliance to Eudralex (Volume 4), which cGMP standards are very proscriptive and rigorous to implement. These standards are similar to those within the pharmaceutical industry and are a notch above the Good Production Practices (GPP) minimum standards required for Canadian cannabis production.
Audits in the Food (Edibles) Industry
With the cannabis-infused food (i.e., “edibles”) industry emerging in Canada, legalization is planned for late 2019.This will bring another set of regulations related to food in conjunction with the cannabis regulations. Safety of these new food products will be a primary consideration given their novelty, with standards expected to be higher than the existing food manufacturing framework. In addition, the Safe Food for Canadians Regulations are being rolled out and will come into full force on January 15, 2019. Quality Management Systems (QMS) based on GFSI benchmarked schemes (e.g., SQF, BRC, FSSC 22000) are also very popular and recognized in the food industry. Very likely these will be adopted into the pending edibles framework. Cannabis Compliance Inc. is offering gap assessments against existing regulations or benchmarked systems, which provides food manufacturers with a perspective of the gaps in their program.
Cannabis Compliance is staffed with individuals with combined decades of experience in food compliance, and when coupled with our depth of experience in the cannabis industry, is the premiere consulting firm of choice to transition established food companies into the edibles industry. Contact us today to start a conversation around auditing.