Section 19 of the Cannabis Regulations names one individual, not a department. Every lot or batch a processing licence holder makes available for sale has to be approved by that person first. Health Canada holds them to a defined standard of training, experience and technical knowledge.
A cannabis quality assurance person, usually shortened to QAP, is the individual a holder of a licence for processing must retain under section 19 of the Cannabis Regulations. The role carries three statutory duties: assuring quality before sale, investigating quality complaints, and investigating any suspected risk to human health.
Buyers in Germany, Australia and Israel ask about this role more often than most Canadian producers expect. They are not checking a box. They want to know whose signature sits on the batch record, and what happens to your release schedule if that person leaves.
What section 19 requires of a Canadian QAP
The requirement attaches to one licence class. A holder of a licence for processing must retain the services of one individual as a quality assurance person. That individual needs training, experience and technical knowledge related to the requirements of Parts 5 and 6, applied to the class of cannabis on the licence. Part 5 sets out Good Production Practices. Part 6 governs cannabis products themselves. Both sit under the Cannabis Act.
A standard cultivation licence on its own does not trigger section 19. That surprises people. It also explains why a cultivator without processing authority cannot release a finished cannabis product for sale or export, because there is no QAP to approve the batch. Our breakdown of cannabis processing licence requirements covers where that line sits.
The three statutory duties
Subsection 19(2) makes the QAP responsible for:
- Assuring the quality of the cannabis before it is made available for sale
- Investigating every complaint received about the quality of the cannabis, and immediately taking measures to mitigate risk where necessary
- Immediately investigating any reasonable suspicion that the cannabis, or anything used as an ingredient, presents a risk of injury to human health, or that Part 5 or Part 6 requirements are not being met
The second and third duties are where complaint handling meets recall. A QAP who investigates a quality complaint and finds a systemic cause is already standing inside the decision that leads to a recall, which is why the two systems should share one record trail rather than two. Our guide to recall requirements for Canadian exporters picks up at that point.
Security clearance, and the site question
The QAP must hold a security clearance under section 50, and so must any designated alternate. That clearance runs as a separate Health Canada process on its own timeline, which our security clearance guide walks through. One thing section 19 does not say is that the QAP must work at the site. Compare section 23, which requires the head of laboratory at an analytical testing licence holder to work at the site set out in the licence. The drafters wrote that requirement in where they wanted it, and left it out for the QAP.
Batch release, approved methods and the export gate
Section 88 is where the role becomes operational. A holder of a licence for processing must ensure that every lot or batch of cannabis is approved by the QAP before it is made available for sale. It also requires that the methods used to produce, package, label, distribute, store, sample and test cannabis were approved by the QAP before they were put into use.
That second point is what trips up newer exporters. Approval is prospective. A method your QAP reviews after a batch has already been tested against it does not retroactively make that batch compliant. Write the method, approve it, then run it.
| What the QAP approves | Provision | Timing |
|---|---|---|
| Production, packaging, labelling, distribution, storage, sampling and testing methods | 88(1)(c) | Before the method is implemented |
| Every lot or batch of cannabis | 88(1)(e) | Before it is made available for sale |
| Preventive control plan for extracts and edible cannabis | 88(1)(d) | Before implementation |
| Complaint and health-risk investigations | 88(1)(a) with 19(2) | On receipt or on reasonable suspicion |
| Mitigation measures following an investigation | 88(1)(b) | Immediately, where necessary |
Delegation became explicit in 2025
SOR/2025-43, the streamlining amendments published in the Canada Gazette in March 2025, added subsection 88(2). The activities assigned to the QAP under paragraphs 88(1)(b) to (e) can also be conducted under the responsibility of that person. In practice a trained quality associate can do the work, provided the QAP holds the accountability and the delegation is documented. The amendment did not dilute the role. It gave legal footing to an arrangement most quality departments were already running.
Where release meets export
Section 89 states that a holder of a licence must not sell or export a cannabis product unless the applicable requirements in sections 90 to 92 have been met. Section 90 requires testing for the quantity or concentration of THC, THCA, CBD and CBDA on each lot or batch, conducted on the final form of the cannabis. Your QAP is not outside that chain. They approved the sampling and testing methods that produced those numbers, which is why a foreign inspector reading your batch file traces the release signature back to the same name every time.
Destination markets then layer their own panels on top. Our comparison of export testing requirements across four markets shows where the Canadian panel stops and German, Australian and Israeli expectations begin, and our GPP audit preparation guide covers how Part 5 evidence gets assembled for inspection. Treat the QAP release record as the spine of the export file rather than an attachment to it.
Alternate QAPs and the continuity risk most producers miss
Subsection 19(3) allows a holder of a licence for processing to designate one or more individuals as alternate quality assurance persons who are qualified to replace the QAP. That wording is recent. From December 2022 until March 2025 the provision capped alternates at two, and SOR/2025-43 removed the cap. A producer running multiple shifts across several classes of cannabis can now build a bench instead of a backup.
Section 20 is the constraint that actually bites. A holder must obtain the Minister's approval before designating or replacing an alternate QAP, and before replacing the QAP with anyone other than the approved alternate. The application has to include the proposed individual's name and date of birth, a description of their qualifications against subsection 19(1), and a declaration signed and dated by the responsible person referred to in section 37. Health Canada may ask for more information before it decides.
The QAP continuity test
Here is where producers get caught. Approval under section 20 is prospective, and security clearance under section 50 runs on its own separate clock. If your only QAP resigns on a Friday and no alternate has been approved, batch release stops until Health Canada approves a replacement and that replacement clears security. Two queues, not one. Three questions will tell you where you stand:
- Do you have at least one alternate QAP already approved by the Minister, rather than merely identified internally?
- Does that alternate hold a current security clearance under section 50?
- Are their qualifications documented against Parts 5 and 6 for every class of cannabis on your licence, including any class added since they were approved?
A producer that answers no to any of the three has a single point of failure sitting on its release function. Fix it before the next audit, not after the resignation letter.
What international importers ask about your QAP
German importers work inside European pharmaceutical law, so their first question usually concerns the relationship between your QAP and their qualified person. The two roles are not interchangeable. Your QAP approves the batch under Canadian law before it is made available for sale. A European qualified person certifies the batch for release onto the EU market after import, under EU-GMP rules. A compliant German consignment carries both signatures at different points in the chain, and neither one substitutes for the other. Our explainer on EU QP batch release for Canadian LPs sets out the European half.
Australian sponsors approach it differently. Under TGO 93, the sponsor holds the evidence that overseas manufacturing steps met a recognised standard, and the batch data behind that evidence came from methods your QAP approved. Israeli distributors ask the plainest version of the question. Who signed, and are they still with you?
Answer those in writing during qualification and you remove the single most common source of back-and-forth in a first order. Name the QAP. Name the approved alternates. State the section 20 approval dates.
AlphaLeaf is a Health Canada Licensed Producer running an indoor facility in Montreal, growing refined genetics finished by hand-trimming rather than machine trim. Our quality systems rest on ISO/IEC 17025 accredited batch testing and full lot traceability, and we hold export authorisation under the Cannabis Act along with the release documentation that German, Australian and Israeli buyers review before a first shipment.
If you are qualifying a Canadian supplier and want to see how a release file is actually assembled before committing to a trial order, talk to our team. We will walk you through a batch record end to end. Names, dates, signatures.
Frequently Asked Questions
Who needs a quality assurance person under Canada's Cannabis Regulations?
Holders of a licence for processing. Subsection 19(1) requires them to retain the services of one individual as a QAP with training, experience and technical knowledge related to Parts 5 and 6 for the class of cannabis on the licence. A cultivation licence on its own does not create the requirement.
What is a cannabis QAP responsible for?
Three duties under subsection 19(2). The QAP assures the quality of the cannabis before it is made available for sale and investigates every complaint about cannabis quality, mitigating risk where necessary. They must also immediately investigate any reasonable suspicion of a risk of injury to human health, or that Part 5 or Part 6 requirements are not being met.
Does a QAP have to approve every batch before sale?
Yes. Paragraph 88(1)(e) requires a processing licence holder to ensure every lot or batch of cannabis is approved by the QAP before it is made available for sale. Paragraph 88(1)(c) separately requires the QAP to approve production, packaging, labelling, distribution, storage, sampling and testing methods before they are implemented.
Can a Canadian Licensed Producer have more than one alternate QAP?
Yes. Subsection 19(3) allows a holder of a licence for processing to designate one or more individuals as alternate quality assurance persons qualified to replace the QAP. SOR/2025-43 removed the previous cap of two. Each alternate needs the Minister's approval under section 20 and a security clearance under section 50.
Does Health Canada have to approve a new QAP before they start?
Yes, unless the replacement is an already-approved alternate. Subsection 20(1) requires the Minister's approval before designating or replacing an alternate QAP, and before replacing the QAP with any individual other than the approved alternate. The application includes the person's name and date of birth, a description of their qualifications, and a signed declaration from the responsible person.
Is a Canadian QAP the same as an EU qualified person?
No. A QAP approves the batch under the Cannabis Regulations before it is made available for sale. The European qualified person certifies it for release onto the EU market after import, under EU-GMP rules. Consignments bound for a German importer carry both approvals, at different points in the chain.
