Health Canada Releases Report on Compliance Monitoring Project
On February 2, the Regulatory Operations and Regions Branch (RORB) released the 2017 Report on Compliance Monitoring: Natural Health Products. The report presents the results from RORB’s compliance monitoring project (CMP); an initiative undertaken to review the manufacturing practices of facilities in the natural health product (NHP) sector. The CMP involved visiting 23 NHP facilities between February to April 2017, to observe their adherence to good manufacturing practices (GMP). The report details any non-compliance that was identified and actions RORB took to address issues.
This review of NHP facilities was intended as a proactive tool for compliance and enforcement of the Natural Health Product Regulations (NHPR) and its GMP requirements for companies who hold a site licence. The facility visits focused on review of NHP manufacturers and importers and the criteria included facility cleanliness and contamination prevention, record keeping, quality control and recall procedures. Inspectors also conducted product testing specific to safety and quality concerns if they deemed necessary.
Results
RORB identified compliance issues at all facilities, ranging in severity as outlined in the Good Manufacturing Practices Guidance Document. Enforcement actions were based on the nature of the issues identified. Companies were provided the opportunity to correct the non-compliance where possible. This included actions up to and including the recall of products in a minority of cases. As of publication of the report, most companies have addressed the issues RORB identified. A progress update is expected to be made available on the remaining companies once the issues are resolved.
For a detailed summary of RORB’s CMP, click here.
Have Questions on the Report?
Further opportunities to engage with RORB are just around the corner! To learn more on the CMP report including future opportunities for education on GMP compliance, register for the Regulatory Forum at CHFA West where Kim Godard, Senior Manager at RORB will be presenting further details on this and other compliance programs underway.
CHFA is working with RORB to move beyond individual compliance projects and to establish a predictable cycle of compliance monitoring supported by industry education and compliance promotion. CHFA will update members on future initiatives for compliance promotion as they are available.
