Good manufacturing practices

Health Canada is supporting drug establishment licence holders by providing temporary measures due to COVID-19. For more information, please visit DEL and GMP temporary measures due to COVID-19.

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What are good manufacturing practices

Good manufacturing practices (GMP) ensure drugs meet the appropriate quality standards for their intended use before they are sold.

To ensure compliance with GMP regulations, Health Canada inspects establishments that fabricate, package/label, test, distribute, import or wholesale drugs. During these inspections, we verify compliance with GMP (Part C, Division 2 of the Food and Drug Regulations). This is a requirement for issuing a drug establishment licence.

To help industry comply with these requirements, we have developed a series of guides and other related documents.

Drug and health product inspections

Health Canada regularly inspects companies that fabricate, package/label, test, import, distribute or wholesale drugs for the purpose of sale in Canada. This helps ensure drugs sold to people in Canada are safe and meet good manufacturing practices.

Health Canada manages a GMP inspection program to verify industry complies with the regulations. To learn more about the drug inspections we conduct each year, you can browse the Drug and health product inspections database.

Information about emerging issues identified through our GMP inspection program is available to the public. For a regular snapshot of the potential health and safety issues we monitor, please visit:

These potential issues relate to companies that fabricate, package/label, test, import, distribute or wholesale drugs for sale in Canada.

Contact us

For general questions about good manufacturing practices, your regulatory obligations and questions on domestic and foreign GMP inspections, email us at: drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca.

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