Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2019-08-15 and last amended on 2018-10-17. Previous Versions

PART 3Good Manufacturing Practices (continued)

Specifications

  •  (1) Every natural health product available for sale shall comply with the specifications submitted in respect of that natural health product under paragraph 5(i) and with every change to those specifications made by the product licence holder.

  • (2) The specifications shall contain the following information:

    • (a) detailed information respecting the purity of the natural health product, including statements indicating its purity tolerances;

    • (b) for each medicinal ingredient of the natural health product, detailed information respecting its quantity per dosage unit and its identity, including statements indicating its quantity and identity tolerances;

    • (c) if a representation relating to the potency of a medicinal ingredient is to be shown on a label of the natural health product, detailed information respecting the potency of the medicinal ingredient, including statements indicating its potency tolerances; and

    • (d) a description of the methods used for testing or examining the natural health product.

  • (3) The specifications and every change to those specifications shall be approved by a quality assurance person.

Premises

[SOR/2018-69, s. 48(F)]
  •  (1) Every natural health product shall be manufactured, packaged, labelled and stored in premises that are designed, constructed and maintained in a manner that permits the activity to be conducted under sanitary conditions, and in particular that

    • (a) permits the premises to be kept clean and orderly;

    • (b) permits the effective cleaning of all surfaces in the premises;

    • (c) permits the natural health product to be stored or processed appropriately;

    • (d) prevents the contamination of the natural health product; and

    • (e) prevents the addition of an extraneous substance to the natural health product.

  • (2) Every natural health product shall be stored under conditions that will maintain the quality and safety of the natural health product.

  • SOR/2018-69, s. 49(F)

Equipment

 Every natural health product shall be manufactured, packaged, labelled and stored using equipment that is designed, constructed, maintained, operated and arranged in a manner that

  • (a) permits the effective cleaning of its surfaces;

  • (b) permits it to function in accordance with its intended use;

  • (c) prevents it from contaminating the natural health product; and

  • (d) prevents it from adding an extraneous substance to the natural health product.

Personnel

 Every natural health product shall be manufactured, packaged, labelled and stored by personnel who are qualified by education, training or experience to perform their respective tasks.

Sanitation Program

 Every natural health product shall be manufactured, packaged, labelled and stored in accordance with a sanitation program that sets out

  • (a) procedures for effectively cleaning the premises in which the activity is conducted;

  • (b) procedures for effectively cleaning the equipment used in the activity;

  • (c) procedures for handling any substance used in the activity; and

  • (d) all requirements, in respect of the health, the hygienic behaviour and the clothing of the personnel who are involved in the activity, that are necessary to ensure that the activity is conducted in sanitary conditions.

  • SOR/2018-69, s. 50(F)

Operations

 Every natural health product shall be manufactured, packaged, labelled and stored in accordance with standard operating procedures that are designed to ensure that the activity is conducted in accordance with the requirements of this Part.

 Every manufacturer, packager, labeller, importer and distributor shall establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of the natural health product that has been made available for sale.

Quality Assurance

  •  (1) Every manufacturer, packager, labeller, importer and distributor shall

    • (a) have a quality assurance person who

      • (i) is responsible for assuring the quality of the natural health product before it is made available for sale, and

      • (ii) has training, experience and technical knowledge relating to the activity conducted and the requirements of this Part; and

    • (b) investigate and record every complaint received in respect of the quality of the natural health product and, if necessary, take corrective action.

  • (2) Every natural health product shall be manufactured, packaged and labelled using only material that, prior to its use in the activity, has been approved for that use by a quality assurance person.

  • (3) Every natural health product shall be manufactured, packaged, labelled and stored using methods and procedures that, prior to their implementation, have been approved by a quality assurance person.

  • (4) Every lot or batch of a natural health product shall be approved by a quality assurance person before it is made available for sale.

  • (5) Every natural health product that is sold and subsequently returned to its manufacturer, packager, labeller, importer or distributor, as the case may be, shall be approved by a quality assurance person before that natural health product may be made available for resale.

  • SOR/2018-69, s. 51(E)

Stability Period

[SOR/2018-69, s. 52]

 Every manufacturer and every importer shall determine the period of time during which, after being packaged for sale, the natural health product will maintain its purity and physical characteristics and its medicinal ingredients will maintain their quantity per dosage unit and their potency when

  • (a) it is stored under its recommended storage conditions; or

  • (b) if it does not have recommended storage conditions, it is stored at room temperature.

  • SOR/2018-69, s. 53

Records

Manufacturers

 Every manufacturer who sells a natural health product shall maintain the following records at the site at which the natural health product is manufactured:

  • (a) the master production document for the natural health product;

  • (b) a list of all ingredients contained in each lot or batch of the natural health product;

  • (c) records of any testing conducted in respect of a lot or batch of raw material used in the manufacture of the natural health product;

  • (d) records of any testing conducted in respect of a lot or batch of the natural health product;

  • (e) a copy of the specifications for each natural health product that is being manufactured at the site;

  • (f) records demonstrating that each lot or batch of the natural health product was manufactured in accordance with the requirements of this Part;

  • (g) a record of each determination made by the manufacturer in accordance with section 52 and the information that supports that determination;

  • (h) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale;

  • (i) a list of all natural health products that are being manufactured at the site; and

  • (j) a copy of the sanitation program in use at the site.

Packagers

 Every packager who sells a natural health product shall maintain the following records at the site at which the natural health product is packaged:

  • (a) records of any testing conducted in respect of the material used to package the natural health product;

  • (b) records demonstrating that each lot or batch of the natural health product was packaged in accordance with the requirements of this Part;

  • (c) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale;

  • (d) a list of all natural health products that are being packaged at the site; and

  • (e) a copy of the sanitation program in use at the site.

Labellers

 Every labeller who sells a natural health product shall maintain the following records at the site at which the natural health product is labelled:

  • (a) records demonstrating that each lot or batch of the natural health product was labelled in accordance with the requirements of this Part;

  • (b) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale;

  • (c) a list of all natural health products that are being labelled at the site; and

  • (d) a copy of the sanitation program in use at the site.

 
Date modified: