NHP Finished Product Testing: A Shifting Focus from the NNHPD
Over the past year, we have seen a shift in focus from Health Canada, who is showing increased communication between their product licencing and site licencing divisions. Quality testing for finished natural health products (NHPs) has been a largely unexamined area for a number of years, and it is now coming into focus. Health Canada is connecting dots and asking more questions about the quality tests conducted on licenced NHPs.
Let’s back up a step. In today’s industry, it is not uncommon for natural health product (NHP) brand owners to delegate the responsibilities of manufacturing, packaging, labelling and importing their products to third-parties: Brand owners have the conceptual ideas for formulations to meet consumer demands, but they lack manufacturing and importing facilities and licenses. In such cases, brand owners achieve their product licenses (or Natural Product Numbers, NPNs), then hire contract manufacturers to produce the products and/or licenced importers to bring the products into Canada for sale. Bringing additional parties into the process introduces potential for a disconnect between the quality information approved by Health Canada during product assessment and the actual testing performed on the finished products themselves. Any discrepancy between approved finished product test protocols and actual finished product testing that goes unnoticed by product licence holders and manufacturers/importers can pose problems during product release and in the site licencing process itself.
As a brand owner, are you sure your licenced products are being tested in the way Health Canada believes they are? Have you conducted your own “connect the dots” evaluation? An audit of three documents can ensure this is the case and eliminate potential problems at the time of product release and during the site licence application and renewal processes.
Let’s start with the first “dot” – the product licence (or Natural Product Number, NPN). Information about the quality testing of the NHP is required to be submitted as part of the product licence application package. Applicants submit a copy of the current product specifications or complete Health Canada’s Finished Product Specifications(FPS) form as part of their application. The FPS is a tool to help companies comply with the quality requirements required for NHPs, which are laid out in Health Canada’s Quality of Natural Health Products Guide. However, unless the FPS is highly customized by a quality professional, it is not an executable document to guide actual product testing. Herein lies where the potential disconnect can occur.
As a product licence holder, submitting the FPS form will suffice for application purposes. However, the product manufacturer and/or testing laboratory will require more information. For example, which methods should be used for testing? Are the tolerance limits used by the testing laboratory acceptable to Health Canada? The best approach here is to develop a custom finished product specification for each product based on the FPS form submitted to Health Canada. This custom FPS will include every required test, as well as the actual test methods, specifications and tolerance limits for each test. But, in our experience, this is often not how finished product testing is approached.
So, what if you don’t have a custom FPS but the product is already being tested? This takes us to the next “dot” in the equation: the finished product test results or Certificate of Analysis (COA). Each lot of product manufactured should tested by a qualified laboratory which issues a COA indicating the various tests, including methods, that are conducted on the finished product and the associated analytical results. These COAs are issued by the product manufacturer and/or testing laboratories, and are based on the finished product specifications that correspond to the particular product. If a product manufacturer and/or testing laboratory is not privy to the information submitted to Health Canada with the application, this could result in the omission of quality tests or the use of unapproved methods. Additionally, Health Canada may have more stringent quality testing requirements than the manufacturing country, so a product tested and found in compliance with, for example, FDA requirements, may be released for sale by a US manufacturer but the same product is not compliant with Health Canada requirements.
How can you confirm your product testing is compliant with your NPN and rectify any disconnects if they are discovered? The answer: A finished product specification (FPS) audit. A FPS audit entails complete review of existing testing completed by the product manufacturer against the FPS submitted to Health Canada with the product licence application package. The purpose of the audit is to ensure these two documents, as well as the product licence itself, are aligned in terms of required testing, ingredient-specific parameters (i.e. assay, potency), test methods and tolerances. If a disconnect is noted, there are two potential options to rectify it. The first would be to amend the current product licence, providing Health Canada with updated finished product specifications reflecting the actual testing performed, provided the actual testing meets the requirements. The second option is to have the product manufacturer and / or testing laboratory revise the specifications they are using in order to comply with the specifications submitted to Health Canada.
Performing this document audit helps ensure your product meets quality requirements before being released for sale and can also ease the site licence application and renewal processes. Over the past year we have seen Health Canada increase their focus on product quality aspects during the site licence application and renewal processes. Comparing COAs submitted during the site licence process with finished product specifications submitted with the produce licence application package is now a regular check Health Canada is performing, leading to an increase in Information Request Notices (IRN) being issued. This trend towards increased quality enforcement can have a domino effect, subjecting manufacturers, importers and product licence holders to undesirable risks if quality testing does not comply with the Natural Health Product Regulations. Non-compliant products currently on the Canadian market could pose a safety risk to consumers and non-compliant COAs reviewed by Health Canada, if warranted, could lead to product recall if safety risks are identified. Likewise, non-compliant products and COAs can result in loss of product licence and suspensions or cancellations of site licences for manufacturing and importing.
NHP Consulting has qualified QA consultants on-staff who can conduct Finished Product Specification audits for your products. We can assist with any associated amendments required for your NPNs, ensuring that your products meet their licence obligations with respect to testing for each and every batch. Contact us today to learn more and see how we can help.