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

Guide to validation – drugs and supporting activities (GUI-0029) - Summary 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. 2023-02-27 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGUI-0029validationdrugs-and-supportingactivitiesproperly qualifyvalidatedrug manufacturing-processesvalidatedrugmanufacturing-facilitiesvalidate drug manufacturing-equipmentanalytical methodssummary Guide to validation – drugs and supporting activities (GUI-0029) - SummaryHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/validation-guidelines-pharmaceutical-dosage-forms-0029.html#purpose Guide to validation – drugs and supporting activities (GUI-0029) - SummaryHTML 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

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.

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