William Morkel, BSc
Senior Quality Assurance and Regulatory Affairs Specialist, dicentra Inc.
Under the current guidelines for Good Manufacturing Practices (GMPs) for Natural Health Products (NHPs), manufacturers and importers of NHPs are required to ensure that their product expiration dates are supported by adequate stability studies. To date, however, the Natural Health Product Directorate (NHPD) of Health Canada has provided little or no guidance in this area, particularly with respect to how to design or execute a suitable study. The NHPD’s recommendation is that industry follows ICH1 guidelines for stability, but these guidelines are designed mainly for drugs and may not always be appropriate for NHPs.
This situation is expected to improve soon. According to Scott Sawler, Director General of the NHPD, the new Evidence for Quality guidance document (Version 3) is set to come out this December and will include a section that deals specifically with NHP product stability. Mr. Sawler made this announcement at the recent CHFA Expo East NHPD Information Session.
This development coincides with the release of the American Herbal Products Association’s (AHPA) new guidance document entitled Shelf Life Dating of Botanical Supplement Ingredients and Products. This document is designed to address stability testing for dietary supplements sold in the United States. Together, these new resources should provide a valuable framework to assist industry, both in Canada and the US, in complying with the regulatory requirements concerning shelf-life stability.
For further information on online GMP training, quality assurance, or regulatory affairs please contact our experts at dicentra.
dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, beverages, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com