Preventative Control Plan: The New Requirement for Edibles and Cannabis Extracts Manufacturing, Part I of II
The Proposed Regulations Amending the Cannabis Regulations which allows the manufacturing and sale of new classes of cannabis are now out, and there are specific requirements for applicants to be aware of if you want to produce cannabis edibles and cannabis extracts.
One of these requirements is to prepare, retain, maintain and implement a written Preventive Control Plan (PCP) to prove you’ve done a complete assessment of risk on all potential hazards associated with production. Showcasing the controls in place to mitigate the identified risks for the production is paramount to safe products for human consumption.
In line with the government’s policy of maintaining consistency with analogous regulatory frameworks, some elements from the Safe Food for Canadians Regulations (SFCR) have been incorporated in the proposed new requirements for cannabis edibles and extracts – the PCP requirement is one of the elements adopted from the SFCR. The Canadian Food Inspection Agency (CFIA) defines a PCP as a written document that demonstrates how risks to food and food animals are identified and controlled.
A PCP details how food safety and other regulatory compliance will be achieved at the manufacturing site. This is based on the internationally recognized CODEX Alimentarius food safety principles along with requirements related to packaging, labelling, grading, standard of identity and other applicable regulatory requirements.
A PCP is a multi-tiered process starting with assembling a team of subject matter experts from various departments at the site to ensure thoroughness in considering all food safety and regulatory aspects. It is important to have management involvement in the process to ensure an effective execution.
As per the Proposed Regulations Amending the Cannabis Regulations, the PCP needs to be signed off by the Quality Assurance Person (QAP) prior to implementation. The QAP is required to have qualifications and competencies to carry out their duties, which include ensuring the quality and safety of all cannabis products, investigating customer complaints, implementing corrective and preventive actions to avoid recurrence, regulatory compliance and the overall management of the Quality System at the site. In a case where the QAP lacks knowledge and competencies related to edibles, the Licensed Processor would be required to retain the services of another individual with the necessary qualifications.
A PCP must be reviewed and updated when there are changes to any of the conditions considered during the PCP development process. This include changes to process, ingredients, regulatory requirement, formulations, responsibilities etc. It is proposed that all the documents and records related to the PCP must be retained for at least two years from the date of implementation.
In a nutshell, development of a PCP is a complex and lengthy process requiring expertise in performing a holistic and thorough risk assessment of all aspects of production for regulatory compliance. Part II of this blog will look deeper into the development of the PCP.
CCI has a team of subject matter experts who can help you with developing your PCP and other compliance requirements for edibles and extracts manufacturing. Contact us to find out how we can help you be successful and compliant with regulations.
Written by: Aparna Gulavane, Quality and Regulatory Consultant