Are you the manufacturer, importer or distributor of a NHP? The Natural and Non-prescription Health Products Directorate (NNHPD) has issued new regulations that may effect how you sell your product. Inline with the current push in North America towards transparency and customer assurance in NHP’s and dietary supplements, the new guidance document strengthens the need for stability testing and the documentation to back it up. Basically, Health Canada will now be more stringent on expiry dates of products and their ingredients, and you as the manufacturer/importer/distributor may be required to provide documentation proving these facts.
On December 1, 2015 the NNHPD issued the new Good Manufacturing Practices (GMP) Guidance Document that relates to the sale of NHP’s in Canada. The document sets out the GMP requirements to ensure the quality of NHP’s before and while they are available for sale.
One of the areas where additional attention is being focused is on the stability/expiry dates of NHP’s available for purchase in Canada. Manufacturers and importers of finished NHP’s are required to determine how long their product can be expected to remain within the licenced specifications under the stated storage conditions. This new legislation will ensure that the products Canadians purchase can be expected to provide the benefits and levels of medicinal and non-medicinal ingredients on the label.
The Guidance Document states that manufacturers and importers shall ensure the expiry date of the product is confirmed by data from accelerated or real-time stability studies. They will also be required to re-evaluate the product shelf life when significant changes are made to the formulation, manufacturing process or package that may affect the product’s stability.
The manufacturer and importer will also be required to have specific GMP evidence to support the stability/expiry date on the product. GMP evidence to confirm the stability/expiry date:
- The Certificates of Analysis (CofAs) that demonstrate that every product meets specifications at expiry;
- Stability testing protocol for a product manufactured at or imported to the site including actions to be taken if the product fails stability;
- The corresponding testing results indicated in the stability testing protocol (i.e. Time=0, Time=6 months, Time=1 year, etc.);
- Relevant SOPs and associated blank record templates related to stability data.
To find out more about this new document and how we can help you ensure you are meeting all regulatory requirements and reduce your risk of a product recall, contact us today.