Here is what HC says here.
Please note that we are still awaiting your response to the query posed below. We require this information in order to continue with the review process of your application.
The proposed quality assurance person must be able to conduct all activities as per Division 4 which includes understanding the analytical results performed to determine the level of microbial and chemical contaminants in the licensed producer's dried marihuana product in order to assure it's quality before it is available for sale. Also, the quality assurance person must be able to understand how to validate methods as required by sections 53(2) and 54(2) of the MMPR. Plus, the quality assurance person must be able to ensure that the equipment, premises, and sanitation program are accurately followed and that the licensed producer's procedure are meeting the requirement of the MMPR as per sections 55, 56, and 57 of the MMPR.
It is important to provide as much details as possible when describing the proposed quality assurance person to demonstrate that the chosen quality assurance person has the proper training, knowledge and technical expertise to conduct this mandate. Please note that Health Canada does not have provide recommendations for quality assurance training. It is on the onus of the licensed producer to demonstrate that the selected quality assurance person is qualified and will be able to conduct their duties as listed under Division 4 of the MMPR.
Please note that the quality assurance person must be able to investigate any complaints received by the licensed producer. If you decide to have a quality assurance person who is only available part-time, you will need to demonstrate in your application how the quality assurance person will be able to investigate complaints in a timely manner, if any complaints are received by the licensed producer. Additionally, if a recall is executed, the quality assurance person is responsible for conducting the recall and will need to advise the Minister on the reason for commencing it. This responsibility requires detailed verifications and a clear understanding of all aspects of Division 4 of the MMPR.
As a reminder, the duties of the quality assurance person are to ensure that the quality of the products at all steps of the production process and to certify that all processes were conducted as per Division 4.
and what they say here, they toss in the whole process from seed! So now QA covers from seed to shipping? So what is it?
The quality assurance person that is designated under section 10 of the application cannot delegate any responsibilities under Division 4 to another individual. This person is responsible to ensure quality at all steps and must ensure that dried marihuana is produced, packaged, labelled and stored in accordance with the SOPs developed, using the proper equipment and within the sanitation program established and all items under Division 4.
Currently the proposed schedule for John Doe is unclear. Given that Mr. Doe is a Consultant, and that the production of marihuana usually extends over a long period of time from sowing of the seeds to drying the product and that production, packaging and labelling may be conducted on daily basis, your proposal still lacks in demonstrating how it will maintain the quality of all dried marihuana before it is made available for sale as per the requirements of Division 4 of the MMPR. Please submit a more detailed description of the work schedule of your quality assurance person to ensure that all steps detailed above will be sufficiently overseen by this person.
As per section 58 of the MMPR, dried marihuana must be produced, packaged, labelled and stored in accordance with standard operating procedures that are designed to ensure that those activities are conducted in accordance with the requirements of this Division. As per section 60, the quality of the product is the responsibility of the Quality Assurance person. Please confirm whether the quality assurance person is full-time or part-time and please provide additional information to demonstrate how they will be able to ensure the quality of the product at all steps.
