Food and Drug Regulations (C.R.C., c. 870)

DIVISION 2Good Manufacturing Practices

C.02.001 [Repealed, SOR/97-12, s. 5.1]

C.02.002 In this Division,

drug

drug[Repealed, SOR/97-12, s. 6]

importer

importer[Repealed, SOR/97-12, s. 6]

medical gas

medical gas means any gas or mixture of gases manufactured, sold or represented for use as a drug; (gaz médical)

packaging material

packaging material includes a label; (matériel d’emballage)

produce

produce[Repealed, SOR/97-12, s. 6]

quality control department

quality control department[Repealed, SOR/2010-95, s. 1]

specifications

specifications means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes

• (a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material,

• (b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and

• (c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. (spécifications)

C.02.002.1 This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents.

Sale

C.02.003 No distributor referred to in paragraph C.01A.003(b) and no importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division.

C.02.003.1 No person shall sell a drug that they have fabricated, packaged/labelled, tested or stored unless they have fabricated, packaged/labelled, tested or stored it in accordance with the requirements of this Division.

• C.02.003.2 (1) No person shall import an active ingredient into Canada for the purpose of sale unless they have in Canada a person who is responsible for its sale.

• (2) No person who imports an active ingredient into Canada shall sell any lot or batch of it unless the following appear on its label:

  • (a) the name and civic address of the person who imports it; and

  • (b) the name and address of the principal place of business in Canada of the person who is responsible for its sale.

Use in Fabrication

C.02.003.3 No person shall use an active ingredient in the fabrication of a drug unless it is fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division.

Premises

C.02.004 The premises in which a lot or batch of a drug is fabricated, packaged/labelled or stored shall be designed, constructed and maintained in a manner that

• (a) permits the operations therein to be performed under clean, sanitary and orderly conditions;

• (b) permits the effective cleaning of all surfaces therein; and

• (c) prevents the contamination of the drug and the addition of extraneous material to the drug.

Equipment

C.02.005 The equipment with which a lot or batch of a drug is fabricated, packaged/labelled or tested shall be designed, constructed, maintained, operated and arranged in a manner that

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

• (b) prevents the contamination of the drug and the addition of extraneous material to the drug; and

• (c) permits it to function in accordance with its intended use.

Personnel

C.02.006 Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic and other training as the Minister considers satisfactory in the interests of the health of the consumer or purchaser.

Sanitation

• C.02.007 (1) Every person who fabricates or packages/labels a drug shall have a written sanitation program that shall be implemented under the supervision of qualified personnel.

• (2) The sanitation program referred to in subsection (1) shall include

  • (a) cleaning procedures for the premises where the drug is fabricated or packaged/labelled and for the equipment used in the fabrication or packaging/labelling; and

  • (b) instructions on the sanitary fabrication and packaging/labelling of drugs and the handling of materials used in the fabrication and packaging/labelling of drugs.

• C.02.008 (1) Every person who fabricates or packages/labels a drug shall have, in writing, minimum requirements for the health and the hygienic behaviour and clothing of personnel to ensure the clean and sanitary fabrication and packaging/labelling of the drug.

• (2) No person shall have access to any area where a drug is exposed during its fabrication or packaging/labelling if the person

  • (a) is affected with or is a carrier of a disease in a communicable form; or

  • (b) has an open lesion on any exposed surface of the body.

Raw Material Testing

• C.02.009 (1) Each lot or batch of raw material shall be tested against the specifications for that raw material prior to its use in the fabrication of a drug.

• (2) No lot or batch of raw material shall be used in the fabrication of a drug unless that lot or batch of raw material complies with the specifications for that raw material.

• (3) Notwithstanding subsection (1), water may, prior to the completion of its tests under that subsection, be used in the fabrication of a drug.

• (4) Where any property of a raw material is subject to change on storage, no lot or batch of that raw material shall be used in the fabrication of a drug after its storage unless the raw material is retested after an appropriate interval and complies with its specifications for that property.

• (5) Where the specifications referred to in subsections (1), (2) and (4) are not prescribed, they shall

  • (a) be in writing;

  • (b) be acceptable to the Minister who shall take into account the specifications contained in any publication mentioned in Schedule B to the Act; and

  • (c) be approved by the person in charge of the quality control department.

• C.02.010 (1) The testing referred to in section C.02.009 shall be performed on a sample taken

  • (a) after receipt of each lot or batch of raw material on the premises of the fabricator; or

  • (b) subject to subsection (2), before receipt of each lot or batch of raw material on the premises of the fabricator, if

    • (i) the fabricator

      • (A) has evidence satisfactory to the Minister to demonstrate that raw materials sold to him by the vendor of that lot or batch of raw material are consistently manufactured in accordance with and consistently comply with the specifications for those raw materials, and

      • (B) undertakes periodic complete confirmatory testing with a frequency satisfactory to the Minister, and

    • (ii) the raw material has not been transported or stored under conditions that may affect its compliance with the specifications for that raw material.

• (2) After a lot or batch of raw material is received on the premises of the fabricator, the lot or batch of raw material shall be tested for identity.