In the winter and spring of 2017 Health Canada inspectors visited 23 companies. The program was called a compliance monitoring to check if a small subset of companies who hold a site license for manufacturing and importing adhere to the Good Manufacturing Practice requirements. Prior to this monitoring program there had not been an on-site inspection program for Site License holders. To date, there has only been a “paper audit” whereby sites are required to submit documentation when renewing their site license. On site inspections would occur if there was concern (through a trade complaint or similar consumer action) as to activities and GMP adherence.
The license renewal is predicated on a trust and honor system. The result of the monitoring program was an indication that on-site visits were clearly long overdue. This was not a full site inspection that is typically conducted with Drug Establishment license holders every two or so years. Rather there was evaluation of particular areas in focus. The result of the visit resulted in action taken ranging from indicating deficiencies to correct to stop sale and recall of certain products. In some cases the site license was revoked. Nearly half all visits found significant deficiencies. Based on this report this is likely be the start of additional and larger scale compliance monitoring programs that may evolve into a standard on-site inspection program similar to that conducted at drug establishment sites.
Here’s the link to the 2017 report on Natural Health Products facility compliance monitoring:
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