Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) has announced a pilot NHP GMP Inspection Program for site license holders. The driver for this pilot was the Evaluation of the NHP Program 2020/2011 to 2014/2015 as released by the Office of Audit and Evaluation and the Public Health Agency of Canada which recommended the use of proactive tools, such as inspections to balance the current paper-based reviews at the site license application and renewal stage.
The development of the inspection framework will ensure alignment with the Self-Care Framework (SCF), which includes implementation of inspections, and is good news for our industry as it provides the opportunity to engage, work with and educate inspectors in demonstrating how outcome based GMPs allow for a variety of methods in achieving compliance versus the prescriptive drug model currently used for DIN products. Under the SCF, this is expected to become the model for most self-care products.
Inspections have begun and will be conducted virtually due to pandemic restrictions and will then move to a combination of on-site, remote or both. The NHP GMP auditors will be trained in NHP GMPs and will NOT be drug inspectors. The branch conducting these audits is the Health Product Compliance & Risk Management bureau versus the DIN GMP auditors which are housed in the Health Product Inspection & Licensing bureau.
This pilot will inform future inspections under a potential permanent GMP inspection program for NHPs while building from the experiences gained from the GMP Compliance Monitoring Projects (CMPs) conducted since 2017.
