Natural Health Product GMP Inspection Pilot

The Natural and Non-Prescription Health Products Directorate of Health Canada has announced the introduction of a GMP Inspection pilot program for natural health product facilities. The program is anticipated to begin in February/March of 2021.  Site inspections are planned to complement the current paper-based process for site licensing (GMP). Goals of the pilot inspection program will be to enhance compliance of the natural health product (NHP) industry with regulatory requirements, prevent non-compliance, and strengthen the protection of the health and safety of Canadians.

All establishments licenced to manufacture or import NHPs, which are deemed as higher risk activities, will be considered for the pilot phase. In order to decide which site will be inspected the NNHPD will consider a variety of risk factors such as regulated activities underway at sites, and relative impact of the activities on product safety and quality. All sites across Canada will be eligible for inspection but foreign sites will be excluded.

Due to the global pandemic and social distancing restrictions in Canada, virtual and on-site inspections may be conducted including the use of approved technology for sharing sensitive business information. An in depth review of the systems and processes that are in place at the establishment will be conducted during inspections, in order to ensure the safety and quality of natural health products at the site. At the conclusion of the inspection a Compliant (C) or Non-Compliant (NC) rating will be assigned to establishments along with a summary report outlining observations noted by the inspector. Sites will then have an opportunity to address the observations with corrective and preventive actions (CAPA). The inspection observations and CAPAs will also be assessed to determine whether further actions on the site licence or product licences, such as a suspension, are necessary.

Health Canada will use the information collected during the pilot program to assist with development of a permanent inspection program. If the permanent inspection program is implemented, all establishments subject to part 3 of the NHP Regulations will be considered for inspection (manufacturer, importer, storage, distributor). Health Canada may then establish a cyclic and risk based inspection schedule similar to the GMP inspection program currently in place for drug establishment license holders regulated by the Food & Drug Regulations.