GMP in Canada: Division 2 rules, GUI-0001 and inspections

In Canada, GMP for drugs is law: Part C, Division 2 of the Food and Drug Regulations, which applies to anyone who fabricates, packages/labels, tests, imports, distributes or wholesales drugs. Health Canada reads those rules in GUI-0001 and checks them in drug establishment licence (DEL) inspections that end in a Compliant (C) or Non-compliant (NC) rating.

GMP stands for good manufacturing practices. Health Canada says they "ensure drugs meet the appropriate quality standards for their intended use before they are sold" (Health Canada). You'll also see "cGMP". That's the US FDA's term for the same idea. The "C" means current: companies have to use technologies and systems that are up to date (FDA).

Good manufacturing practices under Part C, Division 2

Division 2 of the Food and Drug Regulations (C.R.C., c. 870) is current to 2026-09-21 and was last amended on 2026-06-17 (Justice Laws). Antimicrobial agents are outside the Division (C.02.002.1) (Justice Laws). The sections fall into six groups: sale, premises and people; materials and production; quality control; testing; records and samples; and stability and sterile products.

No distributor referred to in C.01A.003(b), and no importer, may sell a drug unless it was fabricated, packaged/labelled, tested and stored, "including during transportation", in line with the Division (C.02.003). The same ban applies to a seller who did that work themselves (C.02.003.1). SOR/2024-238 added the transportation words. An importer of an active ingredient for sale needs a person in Canada responsible for that sale, and the label must show the importer's name and civic address plus that person's Canadian principal place of business (C.02.003.2). An active ingredient used in fabrication must itself meet the Division (C.02.003.3) (Justice Laws).

Premises and equipment must be designed, constructed and maintained for clean, sanitary, orderly work, effective cleaning and contamination control (C.02.004, C.02.005). Each lot is supervised by personnel with training "that the Minister considers satisfactory" (C.02.006). Keep a written sanitation program, plus written health, hygiene and clothing rules. A person with a communicable disease, or an open lesion on exposed skin, stays out of exposed-drug areas (C.02.007, C.02.008).

Test each raw-material lot against specifications before use. Water may be used before those tests finish (C.02.009, C.02.010). Testing before receipt needs vendor evidence the Minister finds satisfactory and periodic complete confirmatory testing. An identity test on receipt is always required. Qualified personnel write the procedures (C.02.011). Keep a recall system, a self-inspection program and a system that holds contract sites to the Division, with exceptions for Canadian DEL-holder sites and MRA recognized buildings where the batch certificate is kept (C.02.012) (Justice Laws).

SOR/2024-238 added C.02.012.1: every lot is fabricated, packaged/labelled, tested and stored, including during transportation, "in a manner that assures the quality of the drug". C.02.013 requires a quality control department on premises in Canada for every fabricator, packager/labeller, wholesaler, distributor referred to in C.01A.003, and importer. A wholesaler or C.01A.003(a) distributor does not have to make that department a separate unit reporting independently of manufacturing, processing, packaging or sales. The QC head approves release for sale or further use, returned goods, raw and packaging materials, and reprocessing (C.02.014).

Test each finished lot against specifications (C.02.018). Packaging materials get an identity and label check after receipt (C.02.016, C.02.017) (Justice Laws). Under C.02.019, packagers/labellers, distributors and importers test a sample after receipt on their premises in Canada, or before receipt only with vendor evidence satisfactory to the Minister plus periodic complete confirmatory testing. A lot with a useful life over 30 days is also identity tested after receipt. MRA recognized buildings with a kept batch certificate, short-lived radiopharmaceuticals, listed non-prescription drugs and a few other products are exempt (Justice Laws).

Keep dosage-form records for 1 year after expiry unless the licence says otherwise (C.02.021) (Justice Laws). Distributors and importers keep a packaged-lot sample in Canada for that same year. Fabricators keep raw-material samples for 2 years after last use (C.02.025). Set the period the drug meets specifications in the sold package, and run a continuing stability program. Sterile drugs need a separate enclosed area, a microbiology-trained supervisor and a method scientifically proven to ensure sterility (C.02.027 to C.02.029). Medical gases skip the sample and stability sections (C.02.030) (Justice Laws).

Fabricate, package/label, import, perform Division 2 tests, distribute or wholesale only under an establishment licence (C.01A.004). API distribution and wholesale are carved out, and so are certain non-biological Schedule C active ingredients. An importer lists each foreign fabricator, packager/labeller and tester, with the building address and GMP evidence (C.01A.005) (Justice Laws).

GUI-0001, Health Canada's GMP guide

GUI-0001, the Good manufacturing practices guide for drug products, is Health Canada's reading of Division 2. The regulation is the binding text. This edition took effect July 1, 2020 and replaced the February 28, 2018 version. It covers pharmaceutical, radiopharmaceutical, biological and veterinary drugs.

APIs are in GUI-0104, natural health products in GUI-0158. Related guides cover sterile drugs (GUI-0119), Schedule D biologicals (GUI-0027), computerised systems (GUI-0050), clinical trials (GUI-0036) and medical gases (GUI-0031, effective 2026-03-04) (guidance list).

For foreign buildings outside the MRA network and not overseen by a PIC/S Participating Authority, GUI-0001 expects confirmatory testing of the first five unique lots of any drug from each foreign building. After that, test at least one lot per year for each dosage form from each fabricator, and each drug at least once every five years (GUI-0001).

The SOR/2024-238 amendments postdate the 2020 edition. Check the guidance list and current regulations before you rely on the guide's wording.

GMP inspections and ratings

Health Canada inspects before it issues a DEL. The POL-0011 service standard for a new application is 250 days, including that first on-site inspection, and the next regular inspection typically follows within 12 months (POL-0011). Domestic cycles:

Cycles can change with compliance history, size, product type, risk and supply-chain importance, and inspections can be unannounced (POL-0011). Compliant (C) means the establishment showed its activities meet the Act and Regulations. Non-compliant (NC) means it did not. Health Canada uses a Compliant result to issue the DEL and to exchange a Certificate of GMP Compliance under an MRA. Report cards are published in the Drug and Health Product Inspections Database, for sites in Canada and abroad. Observations are Risk 1 (critical), Risk 2 (major) or Risk 3 (other) under GUI-0023.

Foreign buildings work differently. A foreign building still has to be listed on the importer's DEL and shown GMP compliant. GUI-0080, published 2025-07-02, accepts the most recent inspection report, no older than 3 years, from Health Canada, an MRA authority or a "qualified authority" (a PIC/S member or the US FDA). Corporate or consultant audits are accepted only for low-risk activities.

Health Canada acceded to the PIC Scheme in January 1999. Its MRA partners are the EU under the CETA Protocol, Switzerland, Iceland, Liechtenstein, Norway, Australia and the UK (Health Canada). The UK agreement has applied since 2021-04-01 (Health Canada). Under an MRA, regulators exchange GMP certificates, and a manufacturer's batch certificate can be accepted without re-testing at import.

Canadian GMP vs FDA cGMP

The US is not an MRA partner of Canada. FDA's drug GMP MRAs are with the EU, Switzerland and the UK. Canada is not one of them. The rows below track what Division 2 and 21 CFR 211 each require.

GUI-0080 accepts FDA inspection reports as qualified-authority evidence for listing a US building on a Canadian DEL. That acceptance alone does not exempt US-made drugs from C.02.019 testing.

GMP training

Canada names no GMP course. C.02.006 requires supervision by personnel with training the Minister considers satisfactory. US 211.25 requires continuing training in the employee's operations and in CGMP, given by qualified people (eCFR).

RegAffairs AI's answer to this question includes a section-by-section table and a clause-level comparison with 21 CFR 211.