Good Production Practices – What Does Health Canada Look For?
Federally regulated holders of a licence under the Cannabis Act must meet the requirements of Part 5: Good Production Practices (GPP) of the Cannabis Regulations. GPPs cover activities in the operations which may be points where possible contamination can be introduced into processes and ultimately compromise product quality and safety.
When it comes to Good Production Practices in a facility, Health Canada looks for two things.
- Is there a written program for the required GPPs?
- Is the written program being followed and properly documented?
Is there a written program for the required GPPs?
Different license classes and different classes of cannabis products have different GPP requirements. There are general GPP requirements for sale, distribution and export of cannabis. There are additional requirements for processing activities to produce for sale, distribution and export. There are testing requirements for products prior to release for sale.
Appendix A and B of Health Canada’s Good Production Practices Guide summarizes GPP requirements by license class and cannabis class. Not all GPPs are required for each type of license class, only those that are applicable. For example, all license classes require GPPs for Standard Operating Procedures (SOPs), storage, distribution and air filtration system but Sale for Medical Purposes License class does not require a sanitation program, equipment and conveyances and separation of incompatible activities.
A GPP report is submitted during licensing stage which identifies the GPPs necessary for your license class and cannabis products. As written programs such as GPP reports are living documents, it is important for program customization to fit the form, function and flow of your approved building and operations.
Is the written program being followed and properly documented?
It is not enough to have a written program on file. Once you are operating, Health Canada inspectors will verify whether GPPs written are implemented in day-to-day operations, and are properly recorded following Good Documentation Practices.
If a program is implemented but not documented, this will be non-compliant. If a program is not implemented as described, this will be non-compliant. Health Canada will expect you to implement what you wrote in your program.
Program implementation and documentation pose their challenges during operations. Often, record keeping becomes onerous and GPPs are viewed as hindrances to success instead of tools to ensure compliance and product safety. A burdensome GPP program is an indication that the program is not tailored to fit your operations. Anything that does not fit eventually leads to problems. In this case, required GPPs cannot be consistently followed and documented.
Time should be taken to review and streamline the program accordingly to avoid and overcome these situations. A well-written, tailored program for your cannabis operations will assure safe and compliant products, safeguard your cannabis license and make operations efficient.