Virtual GMP Inspections – Canada

Importing and selling drugs in compliance Good Manufacturing Practices in Canada requires a substantial effort due to the requirement for organizations to successfully apply for and receive a Drug Establishment License. On-site inspections are a necessary component of the application process for a Drug Establishment License.

In an unprecedented move, Health Canada has announced that it will introduce virtual or offsite GMP inspections for some Drug Establishment License applicants. Starting in January 2020 GMP inspectors will use web-conferencing during certain, pre-selected drug establishment inspections. The conferencing will assist inspectors in their assessment of GMP compliance of DEL applicants.

Once a particular establishment is selected for a virtual (or offsite) inspection, the inspection team will contact the applicant to provide detailed instructions on connecting to the web-conference, including how to use the necessary tools within the application. The inspection will follow the routine steps of introduction and procedures review. The virtual portion of the inspection will contain breaks to allow off-line document review by inspectors. Inspectors may at any time determine whether or not the inspection will also require an on-site inspection portion.

Applicants can expect document reviews to include training records, organizational charts, standard operating procedures and management records of complaints and deviations. All documents, however, which fall under the scope of a GMP inspection may be subject to this method of review. Health Canada will gather feedback from inspectors and stakeholders following virtual inspections to determine the effectiveness of using web conferencing.