Finished Product Specifications Form

 

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

Thank you for your patience and understanding.

Indicates mandatory fields

Primary Brand Name

Primary Brand Name

A. Dosage Form

  • Capsule
  • Tablet
  • Granule
  • Liquid
  • Lotion
  • Extract
  • Tincture
  • Powder
  • Other (specify):

Primary Brand Name

B. Product Type(s) : Select each category of medicinal ingredient present in the product.

  • Plant, alga or fungus
  • Non-human animal material
  • Bacterium
  • Extracts
  • Isolates
  • Enzymes
  • Vitamins
  • Minerals
  • Amino Acids
  • Essential fatty acids
  • Synthetic Duplicates
  • Probiotics
  • Homeopathic

C. Required Test Parameters

Provide tolerance limits for quantity of each medicinal ingredient and the potency for each standardized constituent. Check the box that reflects testing done for the quantity, potency and identity of each medicinal ingredient:

Quantity N/A as this product is homeopathic
Medicinal Ingredient Target Quantity in units as per the label Tolerance limit (upper and lower limits in percent) Assay is performed at the finished product stage for each medicinal ingredient:

Test methods meet those set out in the List of NHPD Recognized Methods (if No, provide test method in Section E)
Quantified by Input, rationale provided in section G
Yes No
           
(for additional rows, attach separate sheets)
Potency (if applicable)
Note: does not apply to homeopathic potency (see Homeopathic Guidance Document)
Potency Constituent Target Amount in units as per the label Tolerance limit (upper and lower limits in percent) If Assay is performed at the finished product stage for each potency constituent:

Test methods meet those set out in the List of NHPD Recognized Methods (if No, provide test method in Section E)
If Raw Material Assay:

Test methods meet those set out in the List of NHPD Recognized Methods (if No, provide test method in Section E)
Yes No Yes No
             
(for additional rows, attach separate sheets)
Identity
Medicinal Ingredient Test methods meet those set out in the List of NHPD Recognized Methods (if No, provide test method in Section E) Tolerance limits meet those set out in Table 1
(if No, provide limits in section F)
Testing occurs at
Yes No Yes No Finished Product Stage Raw Material Stage
             
(for additional rows, attach separate sheets)

D. Attestation of Product Quality

1. General parameters: Identify all test parameters with respect to general requirements and select 'yes' or 'no' for test methods and tolerance limits for each test parameter that is applicable, and indicate whether testing occurs at the finished product or raw material stage. If a test parameter is not applicable for the product select 'N/A' and provide a rationale in Section G.

The finished product meets the tolerance limits set out in Table 1, and test methods meet those set out in the List of NHPD Recognized Methods with respect to the following test parameters:

General parameters:
Test Parameters If not applicable If testing is applicable:
N/A, Rationale provided in Section G Test methods meet those set out in the List of NHPD Recognized Methods (if No, provide test method in Section E) Tolerance limits meet those set out in
Table 1 (if No, provide limits in section F)
Testing occurs at
Yes No Yes No Finished Product Stage Raw Material Stage
Microbial contaminants              
Heavy metals              
Solvent residues              
Stability              

2. Ingredient specific parameters: Identify all test parameters with respect to ingredient-specific requirements and select 'yes' or 'no' for test methods and tolerance limits for each test parameter that is applicable, and indicate whether testing occurs at the finished product or raw material stage. If a test parameter is not applicable for the product select "product does not contain this ingredient" OR 'N/A' and provide a rationale in Section G.

The finished product meets the tolerance limits set out in Table 2, and test methods meet those set out in the List of NHPD Recognized Methods with respect to the following test parameters:

Ingredient specific parameters:
Test Parameters

Please Note: Test parameters apply to medicinal and non-medicinal ingredients
If test parameter is not applicable If test parameter is applicable:
Product does not contain this ingredient N/A, Rationale provided in Section G Test methods meet those set out in the List of NHPD Recognized Methods (if No, provide test method in Section E) Tolerance limits meet those set out in
Table 2 (if No, provide limits in section F)
Testing occurs at
Yes No Yes No Finished Product Stage Raw Material Stage
Pesticides
(for products containing plant material, an alga, a bacterium, a fungus or a non-human animal material or an extract or isolate)
               
Mycotoxin/Aflatoxin
(for products containing peanuts, ginseng, blue-green algae, ingredients of fungal origin)
               
Oxidative stability
(for products containing unsaturated oils)
               
PCBs
(for products containing fish and seal oil)
               
PCDD/PCDFs
(for products containing fish and seal oil)
               
Thiaminase activity
(for products containing horse tail)
               
Antibiotic residues
(for products containing honey or royal jelly)
               
Antibiotic resistance
(for products containing probiotics)
               
Dicyandiamide, Dihydrotriazines, creatinine
(for products containing creatine monohydrate)
               
Diethylene glycol and related compounds
(for products containing glycerin, unless glycerin is a used as a constituent of a capsule)
               
Sterility of Nosodes (for homeopathic products; sterilization technique for nosodes in compliance with the sterility requirements in the HPUS)                
Impurities (must specify impurity):                
Other (must specify):                

3. Dosage form specific parameters: Identify all test parameters with respect to dosage form-specific requirements and select 'yes' or 'no' for test methods and tolerance limits for each test parameter that is applicable. If a test parameter is not applicable for the product select 'N/A' and provide a rationale in Section G.

The finished product meets the tolerance limits set out in Table 3, and test methods meet those set out in the List of NHPD Recognized Methods with respect to the following test parameters:

Dosage form specific parameters:
Test Parameters N/A, rationale provided in Section G Test methods meet those set out in the List of NHPD Recognized Methods (if no, provide test method in Section E) Tolerance limits meet those set out in Table 3 (if no, provide limits in section F)
Yes No Yes No
Uniformity of dosage unit
(for discrete dosage form; e.g. capsule or tablet)
Disintegration/dissolution testing
(for discrete dosage form)
Antimicrobial effectiveness
(for products containing preservatives)
Other (must specify):

E. Test Methods not Specified in the List of Recognized Test Methods

When test method for specific test parameters cannot meet those outlined in the List of NHPD Recognized Methods, provide the test method used and a suitable scientific rationale justifying the use of this test method. For additional rows move cursor to the outside right of the table and press enter.

  • Test Parameter
  • Method
  • Rationale

F. Tolerance limits outside of NHPD Limits

When tolerance limits for specific test parameters cannot meet those outlined in Tables 1, 2 or 3, provide the applicable tolerance limits used and a suitable scientific rationale justifying the excessive limits including support for the safe use of the product in humans (e.g. solvent residue exceed ICH tolerance limits as this product is a tincture containing ethanol). For additional rows move cursor to the outside right of the table and press enter.

  • Test Parameter
  • Tolerance limits
  • Rationale

G. Rationales:

Include scientific rationales to justify quantification by input, absence of testing, test methods not specified in the list of recognized test methods and tolerance limits outside of the NHPD limits. For additional rows go to "Table" and select "Insert", "row below"

  • Test Parameter
  • Rationale

Signature Block

I, the undersigned, confirm that

  1. The information provided in this finished product specification is accurate and complete;
  2. Records (e.g. quality assurance signed specifications, master production document and records of testing conducted) are maintained to support the compliance of the natural health product to these specifications as per the Natural Health Products Regulations;
  3. These records will be available and provided upon request to Health Canada
  • Name of Quality Assurance Officer or other designated official (Print)
  • Signature
  • Date (yyyy/mm/dd)

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