Between February and April of 2017, Health Canada inspectors visited 23 domestic Canadian Site Licence holders in order to assess their compliance with the Natural Health Product Good Manufacturing Practices. Twelve of these companies were importers, four sterile manufacturers and seven non-sterile manufacturers. As you may know, when issuing a Site Licence, the Natural and Non-prescription Health Products Directorate assesses a company’s compliance based on a remote, paper-based evaluation. The purpose of the recent onsite visits by officers from the Regulatory Regions & Operations Branch was to determine how well the paper-based assessments align with reality.
The results were dismal: 11 of the 23 sites, or almost half of the sites, were issued Letters of Intent To Suspend the licences due to what the auditors considered serious violations of GMP.
Fast forward a year and a half, and Health Canada launched their second round of audits from the fall of 2018 to winter of 2019, again visiting 23 sites (representing about 3% of licenced companies). While the exact statistics are not out yet, Health Canada has communicated that the same non-conformance issues keep arising, particularly related to lack of proper Specifications, lack of proper Testing, lack of proper Stability data, lack of proper SOPs (or proper implementation thereof), and lack of proper Quality Technical Agreements.
The consequence for the companies found to be in violation of the GMPs is market disruption and loss of sales due to enforcement actions. The consequence for the industry as a whole is a negative impact on their collective image, as the detractors of natural health products will use these results to question the safety, quality and efficacy of these products, and even elements within Health Canada itself will use them to justify regulatory reforms that are simply not necessary.
So what has gone wrong? In part, the NNHPD does have to bear part of the responsibility. Over the last ten plus years, since the Regulations came into effect, the NNHPD has pared down and toned down the intensiveness and comprehensiveness of the Site Licence application assessments. As a result, many deficiencies that would have been caught in the past have entered the post-marketing stage during which consumers are exposed to the products. Proper reviews of complete and meaningful applications prior to marketing are not only important in catching significant non-conformance issues upfront, but they also provide ongoing and valuable feedback to the industry as to how the NNHPD currently interprets GMP elements. As it stands, the current SL assessment process, in the wake of NNHPD cutbacks and streamlining, lacks the necessary rigor it once had.
Of course, the industry must assume their share of the blame. Unfortunately, GMP compliance just doesn’t get the attention it should within many companies. These companies often recognize their shortcomings and realize the need to bring their operations into full compliance, but due to a perceived lack of immediate enforcement, any actions to redress the situation often get neglected or delayed. If I were to name the primary root cause of GMP deficiencies uncovered during audits, it would be a lack of staff who are qualified to oversee GMP compliance within the facilities or, if they are qualified, staff who overloaded with other duties and cannot give the proper time and attention to their GMP responsibilities.
In light of the increasing wariness and enforcement on the part of Health Canada, companies should ensure that they are meeting GMP, not only to avoid enforcement actions but to ensure that they are selling products that are safe, effective and of high quality. The first step in achieving this goal is to ensure that the facility is equipped with qualified staff, particularly in the important, but often neglected, the role of Quality Assurance. For this reason, many companies will choose to contract out certain QA activities to a qualified third-party consulting firm.
If you’re company is facing a compliance/enforcement situation, or simply a company who wants to be proactive when it comes to ensuring you are meeting your regulatory responsibilities, you may want to consider engaging the services of dicentra with our eighteen years of experience in Site Licencing and GMP compliance as they relate to natural health products.
To learn more, you can visit our website at www.dicentra.com or contact us at 1-866-647-3279.