Good Manufacturing Practices Guide for Drug Products
Health Canada's GMP guidelines (GUI-0001) interpreting the GMP requirements of Part C, Division 2 of the Food and Drug Regulations. Canada is a PIC/S member, so GUI-0001 aligns closely with PIC/S and EU GMP while reflecting Canadian establishment-licensing requirements.
Fabricators, packagers/labellers, testers, importers, distributors, and wholesalers of drugs for the Canadian market holding an Establishment Licence (DEL).
The GMP requirement areas GUI-0001 interprets under Part C, Division 2 of Canada’s Food and Drug Regulations.
- ✓Premises — design, construction and maintenance that prevent contamination and mix-ups
- ✓Equipment — suitable design, cleaning, maintenance and qualification
- ✓Personnel — qualifications, training and hygiene
- ✓Sanitation — written sanitation programmes for premises and personnel
- ✓Raw material testing — identity and specification testing before use
- ✓Manufacturing control — approved master and completed batch production/control records
- ✓Quality control department — independent QC unit with defined authority to release or reject
- ✓Packaging material testing — examination of packaging/labelling against specifications
- ✓Finished product testing — testing against specifications before release
- ✓Records — complete records retained for the required period
- ✓Samples — retention samples of raw materials and finished products
- ✓Stability — data that support the assigned expiry date
Canada is a PIC/S member, so these requirements align closely with PIC/S PE 009 and EU GMP Part I, with Canadian establishment-licensing specifics.
Source: Health Canada GUI-0001 / Food and Drug Regulations, Part C, Division 2. Verify against the current text before relying on it for a submission.
- 01Hold the appropriate Establishment Licence (DEL)
- 02Meet Division 2 GMP requirements as interpreted by GUI-0001
- 03Maintain records and data integrity
GUI-0001 is periodically revised to reflect PIC/S alignment and Food and Drug Regulations amendments.
Health Canada GUI-0001: frequently asked questions
Quick answers to common questions about Health Canada GUI-0001.
What is Health Canada GUI-0001?
Health Canada GUI-0001 — Good Manufacturing Practices Guide for Drug Products — is a guidance issued by the Health Canada — Health Products and Food Branch (Canada). Health Canada's GMP guidelines (GUI-0001) interpreting the GMP requirements of Part C, Division 2 of the Food and Drug Regulations. Canada is a PIC/S member, so GUI-0001 aligns closely with PIC/S and EU GMP while reflecting Canadian establishment-licensing requirements.
Who does Health Canada GUI-0001 apply to?
Fabricators, packagers/labellers, testers, importers, distributors, and wholesalers of drugs for the Canadian market holding an Establishment Licence (DEL).
What are the key requirements of Health Canada GUI-0001?
HC Health Canada GUI-0001 requires, among other things: Hold the appropriate Establishment Licence (DEL); Meet Division 2 GMP requirements as interpreted by GUI-0001; Maintain records and data integrity.
When was Health Canada GUI-0001 last updated?
The current version of Health Canada GUI-0001 dates from November 2020. GUI-0001 is periodically revised to reflect PIC/S alignment and Food and Drug Regulations amendments.
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When Health Canada GUI-0001 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.