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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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Quality requirements for finished natural health products
Quality Requirements for Finished Natural Health Products

Natural Health Products Directorate


Mandate of nhpd
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
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


Relevant sections of nhp regulations
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


Relevant sections of nhp regulations1
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


Relevant sections of nhp regulations2
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


Quality summary report
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


Identity plant plant material alga bacterium fungus non human animal material
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)


Identity extract or isolate of plant plant material alga bacterium fungus non human animal material
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


Identity vitamins amino acids essential fatty acids synthetic duplicates minerals
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)


Identity vitamins amino acids essential fatty acids synthetic duplicates minerals1
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


Identity probiotics enzymes
Identity: Probiotics & Enzymes Synthetic Duplicates & Minerals

  • Probiotics: microscopic, phenotypic and genotypic methods

  • Enzymes: gel electrophoresis, enzyme activity or substrate specificity assays, other verified methods


Purity microbial contaminants
Purity: Microbial Contaminants Synthetic Duplicates & Minerals

  • 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)


Tolerances for microbial contaminants
Tolerances Synthetic Duplicates & Mineralsfor 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


Microbial reduction or sterilization
Microbial Reduction or Sterilization Synthetic Duplicates & Minerals

  • 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


Purity chemical contaminants
Purity: Chemical Contaminants Synthetic Duplicates & Minerals

  • 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)


Tolerancess for chemical contaminants
Tolerancess for Chemical Contaminants Synthetic Duplicates & Minerals


Quantity potency
Quantity & Potency Synthetic Duplicates & Minerals

  • 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


Tolerances for quantity potency
Tolerances for Quantity/Potency Synthetic Duplicates & Minerals

  • 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


Standardization
Standardization Synthetic Duplicates & Minerals

  • 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.


Standardization1
Standardization Synthetic Duplicates & Minerals

  • 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


Manufacturing information
Manufacturing Information Synthetic Duplicates & Minerals

  • 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


Type of manufacturing information
Type of Manufacturing Information Synthetic Duplicates & Minerals

  • 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


Other tests
Other Tests Synthetic Duplicates & Minerals

  • 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


Summary and conclusions
Summary and Conclusions Synthetic Duplicates & Minerals

  • Relevant sections of NHP Regulations

  • Safety Summary Report

  • Evidence Summary Report

  • Quality Summary Report


Questions and answers
QUESTIONS AND ANSWERS Synthetic Duplicates & Minerals

Please send further questions to the following:

nhpd_dpsn@hc-sc.gc.ca

Tel: 1-888-774-5555


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