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.
What this does not cover
stated in the document's own scope- It does not set marketing authorisation requirements; drug submissions are governed elsewhere in the Regulations.
- It does not set establishment licensing procedure, which is Division 1A, though licences depend on GMP compliance.
- Natural health products and medical devices are regulated under separate regulations.
- Health Canada’s GMP guidance interprets the sections; the binding text is the regulation.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Part C, Division 2 of Canada’s Food and Drug Regulations sets the good manufacturing practices for drugs sold in Canada. It applies to everyone who fabricates, packages and labels, tests, imports, distributes or wholesales drugs, and to storage, including during transportation. Its sections cover premises, equipment, personnel, sanitation, raw material testing, manufacturing control, quality control, packaging material testing, finished product testing, records, samples, stability, sterile products and medical gases. Health Canada’s GMP guidance explains how the sections are interpreted.
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.
Legal basis & how it acquires force
A regulation made under the Food and Drugs Act (C.R.C., c. 870). The text consulted was current to 30 September 2026 and last amended on 17 June 2026. Sale is the trigger: an importer or distributor may not sell a drug unless it was fabricated, packaged and labelled, tested and stored, including during transportation, in accordance with Division 2 (C.02.003), and no one may sell a drug they handled except in accordance with it (C.02.003.1). Establishment licences under Division 1A are linked to compliance.
Document structure
| Part | Covers |
|---|---|
| C.02.001–C.02.003.3 — Interpretation and sale | Definitions, the sale prohibitions, and use in fabrication |
| C.02.004–C.02.008 — Premises, equipment, personnel, sanitation | The facility, its equipment, qualified personnel and sanitation programmes |
| C.02.009–C.02.017 — Materials, manufacturing control, quality control | Raw material testing, manufacturing control, the quality control department and its approvals, and packaging material testing |
| C.02.018–C.02.024 — Finished product testing and records | Testing of each lot against specifications, and record retention |
| C.02.025–C.02.030 — Samples, stability, sterile products, medical gases | Retained samples, stability, additional sterile requirements and 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
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Health Canada has been a PIC/S participating authority since January 1999, and its GMP requirements are aligned with the international GMP principles that PIC/S maintains. Canada’s structure differs from the EU’s in two ways a reader should notice: the obligations are written as regulation sections rather than as a guide with annexes, and the duties attach to licensed activities — fabricator, packager and labeller, tester, importer, distributor, wholesaler — rather than to a single release role.
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.
Who must have a quality control department?
Every fabricator, packager and labeller, wholesaler, distributor referred to in C.01A.003 and importer of a drug must have one on its premises in Canada, supervised by qualified personnel (C.02.013). Except for wholesalers and certain distributors, it must be a distinct unit reporting independently of manufacturing, packaging and sales.
Who approves a lot for sale?
The person in charge of the quality control department. No lot or batch may be made available for sale or further use in fabrication without that approval, and returned drugs need the same approval before further sale or use (C.02.014).
How long are GMP records kept?
Records of fabrication, packaging and labelling, finished product testing and storage of a drug in dosage form are kept for one year after the drug’s expiration date, unless the establishment licence specifies another period (C.02.021(1)). Wholesalers, distributors and importers keep sale records that allow recall for the same period (C.02.022(1)).
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.