Official Tips for preparing an initial Drug GMP Inspection

Health Canada provides a new pre-application package to assist organisations in preparing for an initial drug GMP inspection by the Inspectorate.

The package contains, for example, checklists of minimum requirements that should be in place before an inspection. Although this package is primarily intended to be used prior to the submission of a Drug Establishment Licence Application for the activities of wholesaling, importation and distribution products in the Canadian marketplace and health system, some parts can be used to prepare any regulatory inspection.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)