Natural Health Products Regulations (SOR/2003-196)

PART 3Good Manufacturing Practices

Prohibition

• 43 (1) Subject to subsection (2), no person shall sell a natural health product unless it is manufactured, packaged, labelled, imported, distributed or stored, as the case may be, in accordance with this Part.

• (2) A person may sell a natural health product that is manufactured, packaged, labelled, imported, distributed or stored, as the case may be, in accordance with requirements that are equivalent to those set out in this Part if the natural health product is imported.

Specifications

• 44 (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

• 45 (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.

Equipment

46 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

47 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

48 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.

Operations

49 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.

50 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

• 51 (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 shall be approved by a quality assurance person before that natural health product is made available for further sale.

Stability Period

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.

Records

Manufacturers

53 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 by or for the manufacturer 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

54 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 by or for the packager 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

55 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.

Importers

56 Every importer who sells a natural health product shall maintain the following records:

• (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 by or for the importer in respect of a lot or batch of the natural health product;

• (d) a copy of the specifications for the natural health product;

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

• (f) 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; and

• (g) a copy of the sanitation program in use by the importer.

Distributors

57 Every distributor shall maintain the following records at the site at which the natural health product is stored:

• (a) 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;

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

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

Record Maintenance

58 Every person required under this Part to maintain a record that relates to a lot or batch of a natural health product shall maintain that record for a period of one year following the expiry date of the natural health product to which that record relates.

Sterile Natural Health Products

59 Every natural health product that is intended to be sterile shall be manufactured and packaged

• (a) in a separate and enclosed area;

• (b) under the supervision of a person trained in microbiology; and

• (c) using a method scientifically proven to ensure its sterility.

Ophthalmic Use

• 60 (1) Section C.01.064 of the Food and Drug Regulations applies in respect of natural health products except that it shall be read without reference to the words “or parenteral”.

• (2) Section C.01.065 of the Food and Drug Regulations applies in respect of natural health products except that it shall be read without reference to

  • (a) the words “or parenteral”; and

  • (b) the words “or to its common name if there is no proper name”.

Lot or Batch Samples

• 61 (1) Subject to subsection (3), if the Minister has reasonable grounds to believe that a lot or batch of a natural health product made available for sale may result in injury to the health of a purchaser or consumer, the Minister may require the manufacturer, importer or distributor to provide a sample of that lot or batch.

• (2) The sample shall be of sufficient quantity to enable a determination of whether the lot or batch of the natural health product complies with the specifications for that natural health product.

• (3) The Minister shall not require a sample of a lot or batch referred to in subsection (1) to be provided if more than one year has elapsed since the expiry date of that natural health product.

Recall Reporting

62 Every manufacturer, importer or distributor who commences a recall of a natural health product shall, within three days after the day on which the recall is commenced, provide the Minister with the following information in respect of the natural health product:

• (a) the proper name and the common name of each medicinal ingredient that it contains;

• (b) each brand name under which it is sold;

• (c) its product number;

• (d) the number of each lot or batch recalled;

• (e) the name and address of the manufacturer, importer or distributor who commenced the recall;

• (f) the reasons for commencing the recall;

• (g) the name and address of each person to whom the recalled product was sold by the manufacturer, importer or distributor who commenced the recall;

• (h) the quantity of the recalled product that was sold by the manufacturer, importer or distributor who commenced the recall;

• (i) the quantity of the recalled product remaining in the possession of the manufacturer, importer or distributor who commenced the recall;

• (j) if the recall was commenced by a manufacturer, the quantity of the recalled product that they manufactured;

• (k) if the recall was commenced by an importer, the quantity of the recalled product that they imported and the name and address of each person that sold it to them;

• (l) if the recall was commenced by a distributor, the quantity of the recalled product that was sold to them and the name and address of each person that sold it to them; and

• (m) a description of any other action, in respect of the recall, that the manufacturer, importer or distributor who commenced the recall is taking.