Companies must hold a site licence to manufacture, package, label or import natural health products (NHPs) in Canada. The site licence provides assurance that Health Canada approved good manufacturing practices (GMP) for natural health product (NHP) are followed. All products that are released for sale on the Canadian market must be tested for safety and quality. As such each manufacturer/packager/labeller and importer must have adequate quality systems in place to make sure each product consistently meets the established specifications based on Health Canada established standards, set accurate finished product specifications, and use appropriate test methods. Testing on finished products complements the controls employed during the manufacturing and importing processes and is a Health Canada mandatory requirement.
Where test methods exist for testing each medicinal ingredient in a NHP, companies must not rely on quantification by input. Quantification by input is acceptable only if there is no appropriate test method to accurately determine the quantity of a medicinal ingredient in the finished product. An integral part of each NHP safety and quality attributes is its expiry date (shelf life) which translates in the owner of the product having a scientific rationale or a stability program, and subsequently data, available.
The purpose of a stability program is to determine how long the NHP can be expected to remain within its specifications under recommended storage conditions. Without data or a scientific rationale to demonstrate that an NHP meets its label claims at the expiry date, companies cannot reasonably ensure that the NHP is safe, of acceptable quality, and effective until it expires.
As Health Canada is concerned about the wellbeing of Canadians, it is important that the consumers are provided with safe and quality products, the testing of each lot of finished products to prove quality as per the set specifications as well as stability is a mandatory requirement for each NHP.
Source can help create Finished product specifications, create protocols for stability testing and also help with Finished product testing and any stability testing needs. NNHPD is getting stricter with compliance and enforcement so it is important that you do not get caught in that mess and approach Source Nutraceutical Inc. for any testing needs.
