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

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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Champ Valeur
Dernière modification avril 17, 2026, 22:08 (TU)
Créé le avril 17, 2026, 22:08 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2021-06-15 00:00:00
open_canada_keywords {"fr": ["GUI-0029", "validation des médicaments et des activités de soutien", "qualifier correctement", "valider les processus de fabrication des médicaments", "valider les installations de fabrication des médicaments", "valider les équipements de fabrication des médicaments", "méthodes analytiques"], "en": ["GUI-0029", "validation drugs-and-supporting activities", "properly qualify", "validate drug", "manufacturing", "processes", "validate drug manufacturing-facilities", "validate drug", "manufacturing-equipment", "analytical methods"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Guide sur la validation – drogues et activités de soutien (GUI-0029)
update_frequency as_needed