GMP Inspection Pilot Program: NHPs

GMP Inspection Pilot Program: NHPs

In an effort to improve the quality of Natural Health Products (NHPs) produced in (and imported into) Canada, Health Canada is revisiting and implementing a third round of an inspection program for site licensed facilities. Currently, Health Canada issues an NHP Site License following a paper-based review of evidence in support of a facility’s compliance with the Natural Health Product Regulations (NHPR).

Once licensed, a site is required to maintain its compliance with Part 3 of the NHPR, which outlines GMPs [Good Manufacturing Practices] for NHPs. This Pilot Inspection Program aims to strengthen Health Canada’s mandate as a regulating authority and to better protect the health and safety of Canadians. It is also being implemented to support the rollout of the proposed Self Care Framework, which will oversee the regulation of NHPs along with cosmetics and over-the-counter drugs.

As a result of COVID-19 restrictions, during the pilot NHP GMP Inspection Program, inspectors will be first conducting inspections of importers remotely (i.e. through telephone, email, and video conference). A hybrid model will follow afterwards, including a potential Health Canada review of onsite photographs and/or a physical (i.e., onsite) inspection. The goal of the NHP GMP Inspection Program is to better support Health Canada’s Compliance and Enforcement Policy for Health Products (POL-0001).

After completion of the Inspection Pilot Program, Health Canada will post a summary report online which publishes individual inspection findings on the Drug and Health Products Inspections Database (DHPID).

If you manufacture or import NHPs and need more information or assistance in preparing for the NHP GMP Pilot Program, contact Source’s Regulatory Affairs Team today!

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