Guide to validation – drugs and supporting activities (GUI-0029)

Description

This document is for anyone involved in the fabrication, packaging/labelling, testing, importation, distribution and wholesaling of drugs. It describes how to properly qualify and validate drug manufacturing processes, facilities, equipment, utilities and analytical methods.

Resources

Name Format Description Link
Guide to validation – drugs and supporting activities (GUI-0029) HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/validation-guidelines-pharmaceutical-dosage-forms-0029.html
Guide to validation – drugs and supporting activities (GUI-0029) HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/bonnes-pratiques-fabrication/validation/directives-validation-formes-posologiques-pharmaceutiques-0029.html

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