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

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.

Manufacturing Control

• C.02.011 (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall have written procedures prepared by qualified personnel in respect of the drug to ensure that the drug meets the specifications for that drug.

• (2) Every person required to have written procedures referred to in subsection (1) shall ensure that each lot or batch of the drug is fabricated, packaged/labelled and tested in compliance with those procedures.

• C.02.012 (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler of a drug shall maintain

  • (a) a system of control that permits complete and rapid recall of any lot or batch of the drug that is on the market; and

  • (b) a program of self-inspection.

• (2) Every fabricator and packager/labeller and, subject to subsections (3) and (4), every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall maintain a system to ensure that any lot or batch of the drug fabricated and packaged/labelled on premises other than their own is fabricated and packaged/labelled in accordance with the requirements of this Division.

• (3) Subsection (2) does not apply to a distributor if the drug is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities in respect of that drug.

• (4) Subsection (2) does not apply to a distributor or importer if the drug is fabricated or packaged/labelled in an MRA country at a recognized building and both of the following requirements are met:

  • (a) the address of the building is set out in their establishment licence; and

  • (b) they retain a copy of the batch certificate for each lot or batch of the drug that they receive.

Quality Control Department

• C.02.013 (1) Every fabricator, packager/labeller, wholesaler, distributor referred to in section C.01A.003 and importer of a drug shall have on their premises in Canada a quality control department that is supervised by personnel described in section C.02.006.

• (2) Except in the case of a wholesaler or a distributor referred to in paragraph C.01A.003(a), the quality control department shall be a distinct organizational unit that functions and reports to management independently of any other functional unit, including the manufacturing, processing, packaging or sales unit.

• C.02.014 (1) Except in the case of a wholesaler or a distributor referred to in paragraph C.01A.003(a), no lot or batch of a drug shall be made available for further use in fabrication or for sale unless the person in charge of the quality control department approves the sale or the further use.

• (2) A drug that is returned to its fabricator, packager/labeller, wholesaler, distributor referred to in section C.01A.003 or importer shall not be made available for further use in fabrication or for further sale unless the person in charge of the quality control department approves the further sale or further use.

• (3) No lot or batch of a raw material or packaging/labelling material shall be used in the fabrication or packaging/labelling of a drug unless the person in charge of the quality control department approves the use.

• (4) No lot or batch of a drug shall be reprocessed unless the person in charge of the quality control department approves the reprocessing.

• C.02.015 (1) All fabrication, packaging/labelling, testing, storage and transportation methods and procedures that may affect the quality of a drug shall be examined and approved by the person in charge of the quality control department before their implementation.

• (2) The person in charge of the quality control department shall cause to be investigated any complaint or information that is received respecting the quality of a drug or its deficiencies or hazards and cause any necessary corrective action to be taken, in the case where the complaint or information relates to an activity over which the department exercises quality control.

• (2.1) In the case where the complaint or information that is received does not relate to an activity over which the quality control department exercises quality control, the person in charge of the department shall forward the complaint or information to the person in charge of the quality control department that exercises quality control over that activity.

• (3) The person in charge of the quality control department shall cause all tests or examinations required pursuant to this Division to be performed by a competent laboratory.

Packaging Material Testing

• C.02.016 (1) Each lot or batch of packaging material shall, prior to its use in the packaging of a drug, be examined or tested against the specifications for that packaging material.

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

• (3) The specifications referred to in subsections (1) and (2) 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.02.017 (1) The examination or testing referred to in section C.02.016 shall be performed on a sample taken

  • (a) after receipt of each lot or batch of packaging material on the premises of the person who packages a drug; or

  • (b) subject to subsection (2), before receipt of each lot or batch of packaging material on the premises of the person who packages a drug, if

    • (i) that person

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

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

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

• (2) After a lot or batch of packaging material is received on the premises of the person who packages a drug,

  • (a) the lot or batch of the packaging material shall be examined or tested for identity; and

  • (b) the labels shall be examined or tested in order to ensure that they comply with the specifications for those labels.

Finished Product Testing

• C.02.018 (1) Each lot or batch of a drug shall, before it is made available for further use in fabrication or for sale, be tested against the specifications for that drug.

• (2) No lot or batch of a drug shall be made available for further use in fabrication or for sale unless it complies with the specifications for that drug.

• (3) The specifications referred to in subsections (1) and (2) shall

  • (a) be in writing;

  • (b) be approved by the person in charge of the quality control department; and

  • (c) comply with the Act and these Regulations.