Assess.
Steps taken by the site licence holder to ensure that the requirements in the Food and Drugs Act, the Natural Health Products Regulations and in-house standards are met. The steps could include, among others, monitoring and testing of raw and/or packaging materials, tracking of production, maintenance of records and testing of finished products.

Batch. (or lot)
Material that is intended to have uniform composition, character, and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
Batch number.
A distinctive combination of numbers and/or letters that specifically identifies a batch, and appears on documents such as the batch record and certificate of analysis.
Batch record.
Production document that captures the quantity and lot number of all Materials used, as well as production steps in the manufacturing of a single batch of a natural health product in dosage form.
Biomarker.
A distinctive biological or biologically derived indicator (as a biochemical metabolite in the body) of a process, event or condition (as aging or exposure to a toxic substance).
Bulk natural health product.
Unpackaged dosage form, usually in quantities larger than the largest commercially available package size. Bulk preparation. Unpackaged homeopathic preparation, usually in quantities larger than the largest commercially available package size.

DIN (drug identification number).
A numerical code assigned to each drug product marketed under or in accordance with the Food and Drugs Act and Food and Drug Regulations.
Diploma.
A document issued by an educational institution, such as a university, college, or technical institute, vouching that the recipient has earned a degree or successfully completed a particular course of study.
Distributor.
A person who sells a natural health product to another person for the purpose of further sale by that other person.
Dosage form.
The final physical form of the natural health product which may be used by the consumer without requiring any further manufacturing.

Education.
The act or process of imparting or acquiring knowledge or skills; the learning of information by instruction, training, or study can be testified to by a degree, certificate or diploma.
Experience:
Active participation in events or activities leading to the acquirement of knowledge or skills; the knowledge or skills retained from personally observing, encountering, or undergoing something.
Extract.
A substance prepared by treating a plant or a plant material, an alga, a bacterium, a fungus, or non-human animal material with solvents to remove any constituents.

Genus. (Genera, pl.)
A group of closely related species.
Good manufacturing practices.
Measures to ensure an overall effective approach to product quality control and risk management. They apply to places, people, processes and products with respect to which activities are being conducted.

Hazard Analysis and Critical Control Points (HACCP).
An internationally recognized system of food safety methods. It is a systematic approach to the identification, evaluation, and control of food safety hazards that can be applied to other production systems.
Health Canada inspection report.
A written inspection report prepared by an inspector from Health Canada, using either the drug or natural health product good manufacturing practices as the basis for the site assessment.
Health claim.
This is a synonym of a “Recommended Use or Purpose” found within the definition for “Recommended conditions of use”.
Herbarium.
A reference collection of pressed, dried (preserved) botanical specimens.

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Key.
In botany, a plant identification tool; a series of steps where the presence or absence of characteristics eliminates possible choices.

Maceration.
Processing method using unheated solvent (cold or room temperature water, alcohol, or other organic solvent) to extract medicinal properties from a raw material.
Manufacturer.
A person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of the patient, compounds a natural health product for the purpose of sale to that patient.
Manufacture.
To fabricate or process a product for the purpose of sale.
Manufacturing order.
Instructions that outline in detail the materials and procedures required to manufacture, prepare and preserve a single batch of a natural health product in dosage form.
Margin of Safety.
The difference between the minimal therapeutic dose and the minimal toxic dose of a therapeutic substance.
Marker compound:
a constituent that occurs naturally in the material and that is selected for special attention (e.g. for identification or standardization purposes) by a researcher or manufacturer. Marker compounds are not necessarily pharmacologically active.
Master formula.
A document or set of documents specifying the raw materials with their quantities and the packaging materials, together with a detailed description of the procedures and precautions required to produce a specified quantity of a finished product.
Master production document.
A document that includes specifications (raw material, packaging material, packaged dosage form), master formula, sampling procedures and critical processing related standard operating procedures, whether or not these procedures are specifically referenced in the master formula. It also includes a complete list of raw materials used in the manufacture of the product, designated by names or codes; the amount of each raw material required for the theoretical product formulation; manufacturing and process control instructions and in-process testing requirements (e.g. checks on materials, pre-treatments, sequence of adding materials, mixing time and temperatures); a statement of the principal equipment to be used; a statement of the theoretical weight or measure of the manufactured product and the acceptable limits beyond which an investigation is required; a description of the finished product containers, closures and packaging labels; any special precautions to be observed; and dates and times (if applicable) of commencement and completion of significant intermediate stages, such as blending or heating, and of completion of production.
Medicinal Ingredient.
Any substance set out in Schedule 1 of the Natural Health Products Regulations that is intended to furnish pharmacological activity or other direct effect in: (a) the diagnosis, treatment, mitigation, or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; or (b) restoring or correcting organic functions in humans; or (c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
Mother tincture.
A relatively concentrated aqueous alcoholic extract from which subsequent attenuations are prepared. Synonyms: mother liquor, stock solution, starting solution.

Observation.
A deviation or deficiency of good manufacturing practice noted by an inspector or assessor.Organic. A labelling and advertising term that denotes a plant or a plant material, a fungus or a non-human animal material certified to have been produced in accordance with the production, processing, packaging, storage and distribution provisions of the National Standard of Canada for Organic Agriculture. Certification according to other organic standards is also acceptable. Products not within the scope of agricultural standards (e.g. aquatic non-human animal material, algae, cyanobacteria, (“blue-green algae”)) must be certified to have been produced in accordance with an aquacultural or other applicable organic standard.
Organoleptic.
The effect or impression produced by any substance on the organs of touch, taste, or smell, and also on the organism as a whole; in testing the use of these senses to identify specific materials.
Outer Label.
The label on or affixed to the outside of a package of a natural health product.

Package (noun).
Includes anything in which any natural health product is wholly or partly contained, placed or packed.
Package (verb).
To put a product in its immediate container.
Packaging material.
Labels, printed packaging materials and those components in direct contact with the dosage form.
Packaging order.
Instructions that outline in detail the materials and special procedures required to package and label a single lot of a product in dosage form.
Percolation.
A method used for the extraction of dried substances that have been reduced to the proper degree of fineness.
Plant.
In this document, ‘plant’ is considered to not only include flowering plants, but also algae, lichens, mosses, and fungi; a living organism lacking the power of locomotion
Principal Display Panel.
The principal display panel is that part of the inner or outer label applied to all or part of the principal display surface of the container that is displayed or visible under normal or customary conditions of sale or use.
Processing deficiency notice.
A notice issued by the processing unit to request missing information or clarification.
Product.
A substance or combination of substances manufactured or refined for sale. (see also ‘ingredient’)
Production.
All operations involved in the preparation of a finished product, from receipt of materials, through processing and packaging, to completion of the finished product, including storage.
Propagule.
Any structure capable of giving rise to a new plant by asexual or sexual reproduction, including cuttings, seeds, leaf buds, etc.
Proper name.
In respect of an ingredient of a natural health product, one of the following: (a) if the ingredient is a vitamin, the name for that vitamin set out in item 3 of Schedule 1; (b) if the ingredient is a plant or a plant material, an alga, a bacterium, a fungus, a nonhuman animal material or a probiotic, the Latin nomenclature of its genus and, if any, its specific epithet; and (c) if the ingredient is other than one described in paragraphs (a) or (b), the chemical name of the ingredient.
Purity.
The extent to which a raw material or a product in dosage form is free from undesirable or adulterating chemical, biological or physical entities as defined by specification.

Raw material.
Any substance, other than in-process product or packaging material, intended to be used in the manufacture of products, including those that appear in the master formula but that do not appear in the product such as solvents and processing aids.
Recognized building.
In respect of the fabrication, packaging/labelling or testing of a natural health product, a building that a regulatory authority that is designated under subsection(1) in respect of that activity for that natural health product has recognized as meeting its good manufacturing practices standards in respect of that activity for that natural health product.
Recognized institution.
A Canadian or international educational facility (e.g. a university, college or professional or post-secondary institute) generally approved of or having a secure reputation; credible, reputable, and authoritative.
Recommended conditions of use.
With regard to a natural health product:
— its recommended use or purpose;
— its dosage form;
— its recommended route of administration;
— its recommended dose;
— its recommended duration of use, if any; and
— its risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with its use.
Reconciliation.
A comparison, making due allowance for normal variation, between the amount of product or materials theoretically produced or used and the amount actually produced or used.
Reprocessing.
Subjecting all or part of a batch or lot of an in-process product or finished product to a previous step or alternate manufacturing process due to failure to meet predetermined specifications.
Retention sample.
A representative sample of each lot/batch/shipment that is held back by the supplier to allow for future confirmation of identity, quality, etc.; the retention sample will have the same identification number as the lot/batch/shipment from which it has been retained.
Returned product.
Bulk or finished product sent back to the manufacturer, distributor or importer.

Salvage.
To remove unwanted material (i.e., contaminants such as weeds, dirt, and other material other than the target crop or product) from a given batch or lot of product.; the act of saving goods or property that were in danger of damage or destruction
Sampling.
Collection of a number of units that comprises a representative sample from a designated lot or batch of product.
Sell.
Includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration.
Site.
A place of or for a activity specified under the Regulations.
Site licence applicant.
An individual with legal responsibility for the site of manufacturing, packaging, labelling or importation of a natural health product to be sold in Canada.
Site licence number.
A number issued by Health Canada’s Natural Health Products Directorate based on the requirements set out in the Natural Health Products Regulations as proof of authorization to conduct specified activities at the listed locations.
Species.
The narrowest taxonomic grouping; a group of closely related animals or plants that are capable of interbreeding.
Spent herb.
Means the botanical material remaining after the extraction process is complete.
Standardization.
The application of product knowledge, good agricultural or wildcrafting practices, and good manufacturing practices to minimize inherent variations in the composition of natural substances in order to ensure consistent product quality from one batch to the next.
Standard operating procedures.
An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more general nature (e.g. equipment operation, maintenance and cleaning, cleaning of premises and environmental control, sampling and inspection). Certain standard operating procedures may be used to supplement product-specific master production documents.
Standards of Evidence.
Clearly defined criteria used by regulators to evaluate the safety, quality and effectiveness of a claim regarding a health product or food. The criteria define the amount and type of data required to support the safety of a product and all health claims that are associated with it. Although Standards of Evidence may differ from one type of product to another, they are consistent within a similar category of products.
Sterile dosage form.
A dosage form that is free from microbial contamination. Sterile Product. It is a product that is free from viable microorganisms.

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Voucher Specimen.
A representative specimen preserved to permit independent verification of identity and to allow further examination (e.g. pressed plants, non-human animal material in preserving fluids).

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