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Quality Requirements for Finished Natural Health Products

Quality Requirements for Finished Natural Health Products. Natural Health Products Directorate. Mandate of NHPD. Consumers need to know: Is this product safe? Does it do what it says it will do on the label? Is it of good quality?. Assessing Product Quality.

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Quality Requirements for Finished Natural Health Products

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  1. Quality Requirements for Finished Natural Health Products Natural Health Products Directorate

  2. Mandate of NHPD • Consumers need to know: • Is this product safe? • Does it do what it says it will do on the label? • Is it of good quality?

  3. Assessing Product Quality • All finished Natural Health Products must meet the minimum specification requirements for identity, purity, quantity, and potency (if applicable) • Details are provided in the “Evidence for Quality of Finished Natural Health Products Guidance Document” at URL: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/evidence_for_quality_nhp_e.html

  4. Relevant Sections of NHP Regulations • Should be read in conjunction with Part 3 of the NHP Regulations, i.e., GoodManufacturingPractices (GMP), and the GMP guidance document • S. 5 (i) states that a copy of the NHP specifications must be submitted when applying for a product licence

  5. Relevant Sections of NHP Regulations • S. 44 states that the specifications shall contain the following information: (a) Purity & its tolerances (b) Identity, quantity & their tolerances (c) Potency (if applicable) & its tolerances (d) Description of test methods used

  6. Relevant Sections of NHP Regulations • S. 98 deals with labelling & advertising of an NHP in oral dosage form with respect to the site, rate, extent of release or availability of the medicinal ingredient • S. 103 deals with disintegration times of an uncoated, plain coated tablet, enteric coating or similar coating and other related information including labelling & advertising

  7. Quality Summary Report To be submitted with Product Licence Application: • Description of manufacturing process • Sterilization or irradiation of NHP if applicable • Analytical procedures • Justification of specifications including exceptions to testing • Summary template for specifications

  8. Identity: Plant, Plant Material, Alga, Bacterium, Fungus, Non-Human Animal Material • Macroscopic, e.g. comparison with text book and herbarium specimens • Microscopic, e.g. special glandular hairs • Chemical fingerprinting, e.g. high performance liquid chromatography (HPLC)

  9. Identity: Extract or Isolate of Plant, Plant Material, Alga, Bacterium, Fungus, Non-Human Animal Material • Chemical fingerprinting of extracts and/or other chemical analytical methods for extract marker constituents and pure isolates • e.g. HPLC, gas chromatography with mass spectrometry

  10. Identity: Vitamins, Amino Acids, Essential Fatty Acids, Synthetic Duplicates & Minerals • Tests appropriate to the substance, that may include: • Physical description, molecular weight, infrared absorption • Specific rotation (isomers) • Refractive index (liquid)

  11. Identity: Vitamins, Amino Acids, Essential Fatty Acids, Synthetic Duplicates & Minerals • Pharmacopoeial methods e.g., United States Pharmacopeia (USP) • Other verified methods, e.g. by the Association of Analytical Communities (AOAC) International

  12. Identity: Probiotics & Enzymes • Probiotics: microscopic, phenotypic and genotypic methods • Enzymes: gel electrophoresis, enzyme activity or substrate specificity assays, other verified methods

  13. Purity: Microbial Contaminants • Yeast and mould contaminants • Total aerobic count • Escherichia coli • Salmonella spp. • Staphylococcus aureus • Enterobacter spp. • Pseudomonas aeruginosa (only in liquid products with water or less than 50% ethanol)

  14. Tolerances for Microbial Contaminants 1 Units are in Colony Forming Units per gram or per milliliter; 2 Absent means < 1 x 101 CFU/g or 1 x 101 CFU/ml

  15. Microbial Reduction or Sterilization • Irradiation may be used for microbial reduction or sterilizing procedure except for vitamins and probiotics • Sterility test must be included in the specifications for all ophthalmic products and other sterile products

  16. Purity: Chemical Contaminants • Arsenic, cadmium, lead, total mercury • PCBs, PCDDs, PCDFs (e.g., fish oils) • Toxins (e.g., cyanobacterial) • Mycotoxins (e.g., aflatoxins), where necessary • Pesticides (not for certified organic NHP) • Other impurities e.g., solvent residues, radioactivity (if suspected)

  17. Tolerancess for Chemical Contaminants

  18. Quantity & Potency • Quantitative tests: apply to all NHPs • Amount of each medicinal ingredient per dosage unit, e.g. 500 mg vitamin C per tablet • Potency tests: apply to standardized NHPs, e.g. herbs, extracts, isolates, enzymes, essential fatty acids, vitamins • Percentage of an identity marker compound, e.g. 1.5% echinacoside in Echinacea angustifolia root • Percentage of an active ingredient in extract, e.g. 7% GLA in evening primrose oil • Units of activity of vitamin, e.g. 200 mg of d-alpha-tocopheryl acetate providing 272 IU Vitamin E

  19. Tolerances for Quantity/Potency • 80 to 120% of label claim for most NHPs • 80 to 150% of label claim for enzymes • 80 to 300% of label claim for probiotics • Established standards for vitamins, minerals, amino acids & synthetic duplicates e.g. USP

  20. Standardization • The preparation of a consistent product from batch to batch using a master formula that specifies standard operating procedures, materials and manufacturing steps such the extraction ratio and solvent composition.

  21. Standardization • Acceptable methods include mixing batches of raw material (best practice), normalization by adjusting the extraction process or amount of excipients, and pharmacological standardization with a bioassay • Spiking with an isolate or synthetic substance gives a product that is fortified/enriched but not standardized • Provide rationale with respect to standardization and methods used

  22. Manufacturing Information • Required for all non-compendial applications except: • Traditional methods of preparation (e.g. powdered herb, tea, tincture) • Vitamins & minerals • Item 1 of Schedule 1: plant or plant material, alga, bacterium, fungus or non-human animal material

  23. Type of Manufacturing Information • A flow diagram including a description of: • Raw materials, solvents, catalysts, reagents • Yield ranges • The description should reflect: • Representative batch scale for commercial production • Critical steps, process controls, equipment and operating conditions such as temperature, pressure, pH and time

  24. Other Tests • Disintegration time test is required • Tests below are not required but recommended for certain NHPs: • Dissolution • Leak rate and leachability • Uniformity of dosage units • Water (moisture) content

  25. Summary and Conclusions • Relevant sections of NHP Regulations • Safety Summary Report • Evidence Summary Report • Quality Summary Report

  26. QUESTIONS AND ANSWERS Please send further questions to the following: nhpd_dpsn@hc-sc.gc.ca Tel: 1-888-774-5555

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