Quality Assurance and Testing (Finished Product Specification)
Products being sold for human consumption in Canada, the US, and the EU must be confirmed as high quality products.
This means that the manufacturer (or a designate) must follow a carefully designed manufacturing protocol (a “quality system”) and conduct testing to confirm all products contain the ingredients claimed on the labels and are free from harmful ingredients and contaminants. In the supplement category, finished goods are typically tested against parameters laid out on a product-by-product basis (i.e. the confirmatory testing is product specific).
In Canada, a product license application for a natural health product (NHP) must include a formal Finished Product Specification (FPS) document summarizing the tests that will be conducted and outlining the specifications (tolerance limits) to which that product must comply. Guided by the Good Manufacturing Practices (GMP) requirements for all NHPs, FPS documents include the amounts and identities of medicinal ingredient(s) as well as the physical attributes of a product (including stability) and potential harmful contaminants such as pesticide residues, heavy metals, and yeast/mold.
Because every formulation is different, every FPS will be different. Some ingredients require specific, specialized testing that is not required for others, and regulatory authorities may accept a wide range of test methods and tolerances. A stability protocol needs to be customized to ensure that it encompasses the requirements for the different ingredient types that make up a product (for example, stability protocols for probiotics and enzymes differ from those for fish oils and topical products).
Based on over 30 years of combined experience, the Health Products team at NHP Consulting can work with brand owners, manufacturers, and testing labs to create custom FPSs compliant with the GMP requirements of any target market. Our full-service quality support can extend after you have come to market through a number of ongoing quality services.