Canadian Drug GMP: Quality Control Approval, Records and Recall
Map each licensed activity to Division 2, keep lot evidence on premises in Canada and leave release to quality control.
In Short
- QC approves every lot before sale.
- Recall system and self-inspection.
- Keep records 1 year past expiry.
In Canada, Division 2 of Part C of the Food and Drug Regulations (C.R.C., c. 870) sets good manufacturing practices for drugs. No one may sell a drug they fabricated, packaged/labelled, tested or stored unless it was handled under the Division. Establishment licensing provisions were not analysed. Health Canada's GMP guidance (GUI-0001) explains interpretation but was not opened here. This guide covers the regulation text; it is orientation, not legal advice. Sources checked 4 Oct 2026.
The Sale Prohibition
Section C.02.003 bars distributors and importers from selling a drug unless it was fabricated, packaged/labelled, tested and stored, including during transportation, under the Division. Section C.02.003.1 applies the same rule to anyone selling a drug they handled themselves.
More on the Sale Prohibition
Importers of active ingredients need a person in Canada responsible for sale and must label lots with importer details. The practical effect is that GMP evidence has to exist before a sale, not after a request, and transportation and storage conditions are part of the record, not an afterthought.
Written Procedures and Recall
Section C.02.011 requires fabricators, packagers/labellers, certain distributors and importers to have written procedures prepared by qualified personnel to ensure the drug meets its specifications, and to fabricate, package/label and test every lot under those procedures. Section C.02.012(1) requires a system of control that permits complete and rapid recall of any lot on the market, and a programme of self-inspection.
More on written Procedures and Recall
A recall test is only meaningful if lot genealogy from raw materials through distribution can be retrieved quickly, so mock recalls and self-inspection findings should be recorded and followed up.
Quality control approves, not the system
Section C.02.014 is explicit: no lot of a drug may be made available for sale or further fabrication unless the person in charge of the quality control department approves it. The same approval is needed before using raw material or packaging/labelling material lots, before reselling returned drugs and before reprocessing.
Worked Example: Release of Lot CA-7710
More on quality control approves, not the system
Software can present the evidence, flag missing results and record the decision, but the release decision stays with the named quality control person. Finished product testing under C.02.018 and raw material testing feed that decision.
Records you must keep
Section C.02.020 lists records to keep on premises in Canada for each drug: master production documents; evidence that each lot was fabricated, packaged/labelled, tested and stored under them; evidence that conditions met the Division; and evidence supporting the period during which the drug meets its specifications. Section C.02.021(1) requires records for a drug in dosage form to be retained for one year after the drug's expiration date unless the establishment licence specifies another period.
More on records you must keep
Active ingredient records follow separate periods in C.02.021(2), based on retest or expiry dates.
Worked approach for a new site
Map each licensed activity to the sections that apply, because the Division assigns duties by role: fabricator, packager/labeller, tester, distributor, importer or wholesaler. For each, list the procedure, the record that proves it, the person who approves and the retention period.
Who does what under Division 2 (extract)
| Section | Duty | Applies to |
|---|---|---|
| C.02.011 | Written procedures; lots made to them | Fabricator, packager/labeller, distributor, importer |
| C.02.012(1) | Recall system; self-inspection | Includes wholesalers |
| C.02.014 | QC approval before sale or use | All except wholesalers and some distributors |
| C.02.021(1) | Keep records 1 year after expiry | Drugs in dosage form |
- C.02.011
- Duty
- Written procedures; lots made to them
- Applies to
- Fabricator, packager/labeller, distributor, importer
- C.02.012(1)
- Duty
- Recall system; self-inspection
- Applies to
- Includes wholesalers
- C.02.014
- Duty
- QC approval before sale or use
- Applies to
- All except wholesalers and some distributors
- C.02.021(1)
- Duty
- Keep records 1 year after expiry
- Applies to
- Drugs in dosage form
More on worked approach for a new site
Check transport and storage evidence, which the regulation names repeatedly. Amendments in recent years, including SOR/2024-238, changed wording in this Division, so read the current consolidated text and Health Canada guidance before finalising procedures. Your quality and regulatory people decide applicability.
Questions
Who must approve a drug lot before sale in Canada?
The person in charge of the quality control department, under section C.02.014(1), except for wholesalers and certain distributors.
How long must Canadian drug GMP records be kept?
For a drug in dosage form, one year after its expiration date unless the establishment licence specifies another period, under section C.02.021(1).
Is a recall system required?
Yes. Section C.02.012(1) requires a system permitting complete and rapid recall of any lot on the market, plus a self-inspection programme.
Does storage during transport count?
Yes. Sections C.02.003 and C.02.020 refer to storage including during transportation, so transport conditions belong in the lot evidence.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
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