Food and Drug Regulations — Part C, Division 2: Good Manufacturing Practices
The GMP requirements in Canadian law. Part C, Division 2 of the Food and Drug Regulations sets out, as binding provisions rather than guidance, the premises, equipment, personnel, sanitation, raw-material testing, manufacturing control, quality-control department, packaging-material testing, finished-product testing, records, samples, stability and sterile-product requirements for drugs sold in Canada. Health Canada’s GUI-0001 interprets this Division; an inspector cites the Division.
Always verify against the current published text before relying on it for a submission or inspection.
Scope & applicability
Fabricators, packagers/labellers, testers, distributors, importers and wholesalers of drugs for the Canadian market, and — since the 2013 active-ingredient amendments — fabricators, packagers/labellers, testers, importers, distributors and wholesalers of active ingredients. C.02.002.1 excludes antimicrobial agents from the Division entirely, and C.02.030 disapplies the sample-retention, expiry-period and stability sections to medical gases.
Quick reference · Division 2 retention periods
How long Part C, Division 2 requires records and samples to be kept. Every row is subject to the same override: an establishment licence may specify a different period.
| What | Retention period | Section |
|---|---|---|
| Fabrication, packaging/labelling, finished-product testing and storage records — drug in dosage form | One year after the drug’s expiration date | C.02.021(1) |
| Same records — active ingredient with a retest date | Three years after the lot or batch has been completely distributed | C.02.021(2)(a) |
| Same records — active ingredient without a retest date | One year after the lot or batch expiration date | C.02.021(2)(b) |
| Raw-material and packaging/labelling-material testing records | Five years after the materials were last used | C.02.021(3) |
| Records of sale enabling recall — drug in dosage form | One year after that lot or batch expires | C.02.022(1) |
| Retention sample — packaged/labelled drug (distributor, importer) | One year after the drug’s expiration date | C.02.025(1) |
| Retention sample — raw materials (fabricator) | Two years after the materials were last used in fabrication | C.02.025(2) |
| Retention sample — active ingredient with a retest date (fabricator) | Three years after complete distribution | C.02.025(3)(a) |
Where a fabricator owes sample retention under both C.02.025(2) and (3) for the same active ingredient, C.02.025(4) requires the longer period. These are legal minimums, not a retention policy — a licence condition, another jurisdiction or a marketing authorisation can require longer.
Source: Food and Drug Regulations, C.R.C., c. 870, Part C, Division 2, ss. C.02.021, C.02.022, C.02.025 (Department of Justice consolidation, current to 2026-06-21). Verify against the current text before relying on it for a submission.
Key requirements
- C.02.013: hold a quality control department on premises in Canada that is a distinct organizational unit reporting to management independently of manufacturing, processing, packaging and sales
- C.02.014: no lot or batch is made available for further use in fabrication or for sale until the quality control department approves it
- C.02.009 and C.02.010: test each lot of raw material against its specifications before use, on a sample taken after receipt or before use
- C.02.018 and C.02.019: test each lot against the drug’s specifications before release, and perform the finished-product testing on a sample of the packaged/labelled drug
- C.02.020: maintain master production documents and evidence of fabrication, conditions, expiry support and finished-product testing on premises in Canada
- C.02.021 and C.02.022: retain records for the Division 2 periods — one year past expiry for dosage-form records, five years for raw-material and packaging-material testing
- C.02.023 and C.02.024: handle complaints on receipt and run a self-inspection programme with records of results and any corrective action
- C.02.028: monitor stability by a continuing programme that supports the established expiry period
- C.02.029: fabricate and package a drug intended to be sterile in separate enclosed areas, supervised by personnel trained in microbiology, by a method scientifically proven to ensure sterility
Implementation tips
- Read Division 2 alongside Division 1A: the establishment-licence provisions in C.01A.003 decide which Division 2 obligations attach to you, and several Division 2 sections are written by reference to a paragraph of C.01A.003 rather than to a job title.
- The retention periods are minimums that an establishment licence can lengthen — every one of C.02.021, C.02.022 and C.02.025 carries the phrase "unless the relevant establishment licence specifies some other period". Check the licence before setting a retention policy from the regulation alone.
- Do not assume a PIC/S-aligned system already satisfies Division 2. Canada’s independence of the quality control department (C.02.013(2)) and its on-premises-in-Canada record requirement (C.02.020(1)) are Canadian specifics that a European system will not have addressed.
Revision notes
The Department of Justice consolidation is current to 2026-06-21 and the Regulations were last amended 2026-06-17; within Division 2 the most recently amended section is C.02.020 (2026-06-04). The 2013 amendments (SOR/2013-74) extended the Division to active ingredients, and SOR/2024-136 made further amendments across the Division.
Where this control fails
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C.R.C., c. 870, Part C, Div. 2: frequently asked questions
Quick answers to common questions about C.R.C., c. 870, Part C, Div. 2.
What is C.R.C., c. 870, Part C, Div. 2?
C.R.C., c. 870, Part C, Div. 2 — Food and Drug Regulations — Part C, Division 2: Good Manufacturing Practices — is a regulation issued by the Health Canada — Health Products and Food Branch (Canada). The GMP requirements in Canadian law. Part C, Division 2 of the Food and Drug Regulations sets out, as binding provisions rather than guidance, the premises, equipment, personnel, sanitation, raw-material testing, manufacturing control, quality-control department, packaging-material testing, finished-product testing, records, samples, stability and sterile-product requirements for drugs sold in Canada. Health Canada’s GUI-0001 interprets this Division; an inspector cites the Division.
Who does C.R.C., c. 870, Part C, Div. 2 apply to?
Fabricators, packagers/labellers, testers, distributors, importers and wholesalers of drugs for the Canadian market, and — since the 2013 active-ingredient amendments — fabricators, packagers/labellers, testers, importers, distributors and wholesalers of active ingredients. C.02.002.1 excludes antimicrobial agents from the Division entirely, and C.02.030 disapplies the sample-retention, expiry-period and stability sections to medical gases.
What are the key requirements of C.R.C., c. 870, Part C, Div. 2?
HC C.R.C., c. 870, Part C, Div. 2 requires, among other things: C.02.013: hold a quality control department on premises in Canada that is a distinct organizational unit reporting to management independently of manufacturing, processing, packaging and sales; C.02.014: no lot or batch is made available for further use in fabrication or for sale until the quality control department approves it; C.02.009 and C.02.010: test each lot of raw material against its specifications before use, on a sample taken after receipt or before use; C.02.018 and C.02.019: test each lot against the drug’s specifications before release, and perform the finished-product testing on a sample of the packaged/labelled drug.
When was C.R.C., c. 870, Part C, Div. 2 last updated?
The current version of C.R.C., c. 870, Part C, Div. 2 dates from June 2026. The Department of Justice consolidation is current to 2026-06-21 and the Regulations were last amended 2026-06-17; within Division 2 the most recently amended section is C.02.020 (2026-06-04). The 2013 amendments (SOR/2013-74) extended the Division to active ingredients, and SOR/2024-136 made further amendments across the Division.
This standard in practice
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