The purpose of this guidance document is to give stakeholders directions on how to be compliant with Natural Health Products Regulations (NHPR) and to meet the quality requirements. Product license holders are responsible and are expected to meet the quality requirements for all types of their Natural Health Products (NHP) that fall under the NHPR.
Through the NPN application, the product license applicant provides attestation and confirms that the product will be manufactured, packaged, labeled, imported, distributed, and stored in accordance with good manufacturing practices (GMPs). Health Canada has developed several tools in regard to ingredient-specific quality and specification requirements, such as the Natural Health Products Ingredients Database (NHPID), Finished Product Specifications (FPS), and NNHPD pre-cleared monograph.
License holders may also follow applicable pharmacopeias rather than the tools listed above if it is more appropriate for the ingredient or product.
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Characterization, identification, and quantification standards
The Natural and Non-Prescription Health Products Directorate (NNHPD) requires the characterization of medicinal ingredients to evaluate evidence of its identity, which relates to the safety and efficacy of the Natural Health Product. The characterization could be the ingredient’s distinguishing features or special qualities. Examples are chemicals (e.g. isolates, synthetic duplicates), processed ingredients, and extracts (e.g. fortified extracts, standardized extracts). Depending on the type of ingredient, identity testing may also be required and may be performed at the raw material or finished product stage. This is to determine the correct ingredient or plant species/plant parts from adulterants.
The finished Natural Health Product specifications should list the quantity per dosage unit of all medicinal ingredients. Tolerance limits should be 80-120% of label amount or conform to the applicable pharmacopeial standards. It could be either Quantification by assay (tested at finished product stage) or Quantification by input, depending on the characterization of medicinal ingredients.
The NHPR requires the finished product specifications to list out the information related to the purity of the Health Canada Natural Health Products. This means to include test methods and tolerance limits for Microbial Contaminants and Chemical Contaminants. If this is tested at the raw material stage, it is not required to repeat the test again at the finished product stage as long as GMPs are in place to prevent additional contaminants.
Microbial contaminants testing includes Total viable aerobic plate count, Contaminating fungi (yeast and mold), Salmonella SPP, Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa. Chemical contaminants are elemental impurities such as heavy metals. This can be tested individually, or as total heavy metals with acceptable test methods in NHPID, Pharmacopeial, or internationally accepted
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methods. Topical products have different requirements for heavy metal limits. Depending on the ingredients in the Natural Health Product, other contaminants testing include aflatoxin, cyanobacterial toxins, animal hormones, pesticide residues, solvent residues, antibiotic residues, radioactivity, oxidative stability, and marine oil contaminants.
Additional tests and criteria
Product license holders must ensure all non-medicinal ingredients are within restrictions in NHPID and are used in quantities to support the purpose of its use. Other performance tests may be required depending on the nature of the product, including Disintegration, Dissolution, Uniformity of dosage units, Antimicrobial effectiveness testing, and Stability testing.
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