GMP Audits for Site Licences in Canada

Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) provided a glimpse of some proposed changes in their Six-Month Calendar of Activities for January-June 2017. The last one on the list, Compliance Monitoring Projects, has to do with on-site auditing of GMP compliance. This one may be of particular interest to those facilities with a site license, and those facilities in the application stages.

This is the second time the NNHPD has hinted at plans to enhance the current paper-based site-license model because of limitations of the current model such as accuracy (or lack of accuracy) of information provided in written applications, false or misleading information submitted by sponsors, and export challenges due to a lack of confidence by foreign regulators.

By conducting on-site GMP compliance evaluations, the NNHPD will be able to gain a better sense of the current state of GMP compliance of site licence applicants/holders. The audits may also provide more specific information to Health Canada on the appropriate level of oversight required for these facilities.

At this time the announcements have indicated that manufacturers, packagers, labellers and importers may elect to undergo an independent on-site audit to demonstrate compliance with the GMP standard as part of an on-site audit pilot. Audits would be conducted by a Health Canada recognized third-party auditor. The same level of scrutiny and regulatory oversight will apply to facilities located in Canada or elsewhere in the world.

Similar to the proposed new regulations for self-care products in Canada, a risk-based approach will be used for the on-site audit program. Higher risk sites such as those involved in manufacturing and packaging of natural health products will be a priority over importers and warehouse/storage facilities.