Every natural health product must be manufactured to product consistent composition within certain tolerances. The test methods and tolerances are collectively called the Finished Product Specifications (FPS).
Every natural health product available for sale must comply with pre-approved finished product specifications prior to release. Finished product specifications include the amount of medicinal ingredient (s), confirmation of identity, physical attributes and potential impurities.
In order to label a natural health products in Canada the rule of thumb is the test result has to be within 80-120% of the label claim. Health Canada will expect overages of certain active ingredients based on how stable the ingredient is in the final formulation. While preparing finished product specifications, NHP Consulting will review each ingredient’s degradation profile and how compatible it is with other ingredients in the formulation.
For example, vitamins, probiotics and enzymes tend to degrade fairly quickly. Ingredients in liquid format can interact easily with other ingredients and can form unwanted “complexes”. NHP Consulting uses past knowledge and regulatory tools like the Health Canada approved Pharmacopeia’s to develop finished product specifications. For example vitamin D has an upper limit in the United States Pharmacopeia of 165% of the labelled amount. This would suggest a hefty overage is required.
NHP Consulting will also prepare a full list of potential impurities to test based on the ingredients and the corresponding tolerance limits. Examples are microbial contamination, heavy metals, pesticides (if applicable), and solvent residues (if applicable). There are also physical attributes like dosage uniformity and disintegration that should be tested prior to release. We can suggest cost saving strategies based on test results from your suppliers of raw materials or finished product.
NHP Consulting will prepare a custom FPS to suit your needs.