What happens when you find yourself, a Canadian natural health product (NHP) brand owner, manufacturer, or importer, without the in-house experience necessary to meet Good Manufacturing Practice (GMP) guidelines? Large and small companies alike struggle with GMP and quality assurance (QA) from time to time – sometimes as a result of being new to industry and GMP requirements, and other times due to staffing shortages, employee leaves, changes to your products or systems, or the scale of your business not requiring a full-time quality person. Do you need to close up shop until you have a full-time need or while you find and train new staff? The answer is NO and here’s the reason why.
Let’s start with QA itself, which is a requirement for businesses dealing with natural health products, and also for businesses handling foods, cosmetics, drugs, medical devices, and some other products. Regulated products must be handled strategically from manufacture to end-use, and Health Canada and other regulatory bodies require the use of refined processes (a “quality system”) in all aspects of the supply chain. QA systematically confirms that a quality system is working: It is the processes and tests that prove to stakeholders the products produced by a system meet the safety and quality requirements applicable to those products.
Day-to-day management of a company’s QA rests with the Quality Assurance Person (QAP), an individual who must have the specialized knowledge, experience, and training required to manage a regulated product. The QAP is responsible for ensuring quality at all stages – from raw materials through to the packaged finished product. QAPs confirm product quality prior to release onto the market and must also ensure the quality of the product is retained after it hits the shelves. Understandably, different methods can be used to confirm product quality, and not all QA responsibilities have to be handled in-house. Let’s look next at how the QAP ensures product quality. For this, we need to look more closely at GMPs.
GMPs are specific measures designed to ensure consistent product quality and safety. With the aim of minimizing risk, GMPs include step-by-step procedures and documentation (records) for each step in a process: Think of them like a recipe in which a cook takes photographs at defined points to show (record) what a meal looks like at each stage in the process from the basic ingredients (eggs, cocoa, flour, milk) to the finished product (a chocolate cake). GMPs are divided into specific subsets, such as premises, equipment, personnel and others to ensure safe and consistent products throughout all stages of manufacture and distribution. Implementing GMPs reduces the risk of failing quality tests at the finished product stage, at which point a quality error may be detected at too late a stage to correct, resulting in costly loss of product. Although finished product testing can provide a snapshot of finished product quality, it cannot be relied upon to give an overall picture of where and when a quality failure occurred.
Returning to the role of the QAP, it is clear that this person must have intricate knowledge of GMPs, precise attention to detail, and a keen sense of accountability. Finding and retaining a qualified QAP for on-site oversight of quality assurance is challenging for many companies, which is where remote quality assurance services can save a company time and money by bridging gaps in expertise and manpower.
What, exactly, do remote quality assurance services look like? Here’s an example. Canadian importers of NHPs are responsible for assuring the quality of the NHPs they import before making these products available for sale in Canada. “Assuring the quality of the NHPs” includes reviewing each product’s test results against the finished product specifications on file with Health Canada for that product, and this review must occur for every lot of product before it is released for sale. This review is a technical assessment of laboratory results, and it requires the ability to interpret and evaluate scientific data. If a facility is ever audited for GMP compliance by Health Canada, the auditor will almost certainly request copies of each product’s finished product specifications along with the laboratory results for product lots already released to the market.
Backing up a step, finished product specifications are standardized documents that outline specific criteria about a product: What it looks and smells like, how quickly it dissolves in water, how much the capsule weighs, how much Vitamin C it contains, and so on. Each NHP must conform to its finished product specifications in order to be considered acceptable for sale on the Canadian market. Finished product specifications include the tests required by Health Canada, as well as specify the laboratory methods to be used in testing and the appropriate tolerance limits (range of results) acceptable for each test. Once an importer receives a product and its test results, the results can be reviewed remotely by a “remote QAP”, who proves a release notification to the importer after confirming that the product is in line with its specifications. If the product fails to meet the requirements of any test in its finished product specification, it is not considered acceptable for release, and the importer would be notified to reject the product. In the case of a rejection, the remote QAP can provide assistance on the next steps, guiding a necessary investigation into why the product failed the quality test and recommending corrective actions to prevent future failures of the same type.
Having QA services performed remotely allows your team to meet quality requirements without a full-time scientist on staff. It can free up the time of your on-site employees for the work they were hired to do and ensures the detailed and complex documents involved in QA are reviewed and created by people with the correct combination of credentials and experience.
NHP Consulting has qualified QA consultants on-staff who can provide remote QA services for your business. We can assist with remote product release, product quality investigations, customer complaints, record review and can also create customized Standard Operating Procedures (SOPs) compliant with GMPs to ensure an effective quality system from the ground up. If an on-site QAP makes more sense for your company, NHP Consulting can also help you recruit and train a qualified candidate. Contact us today to learn more and see how we can help.