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

Regulations are current to 2017-08-27 and last amended on 2017-06-20. Previous Versions

Manufacturing Control

  •  (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.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 13.
  •  (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.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 13;
  • SOR/2000-120, s. 9;
  • SOR/2002-368, s. 9;
  • SOR/2013-74, s. 8.

Quality Control Department

  •  (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.

  • SOR/82-524, s. 3;
  • SOR/89-174, s. 8(F);
  • SOR/97-12, s. 55;
  • SOR/2000-120, s. 10;
  • SOR/2010-95, s. 4;
  • SOR/2013-74, s. 9.
  •  (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.

  • SOR/82-524, s. 3;
  • SOR/89-174, s. 8(F);
  • SOR/97-12, ss. 14, 55;
  • SOR/2010-95, s. 5;
  • SOR/2013-74, s. 9.
  •  (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.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 15;
  • SOR/2010-95, s. 6.

Packaging Material Testing

  •  (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 Director 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.

  • SOR/82-524, s. 3;
  • SOR/89-174, s. 8(F).
  •  (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 Director 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 Director,

      • (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.

  • SOR/82-524, s. 3;
  • SOR/89-174, ss. 2(F), 8(F);
  • SOR/97-12, s. 56(F).

Finished Product Testing

  •  (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.

  • SOR/82-524, s. 3;
  • SOR/2013-74, s. 10.
  •  (1) A packager/labeller of a drug, a distributor referred to in paragraph C.01A.003(b) and an importer of a drug other than an active ingredient shall perform the finished product testing on a sample of the drug that is taken either

    • (a) after receipt of each lot or batch of the drug on their premises in Canada; or

    • (b) before receipt of each lot or batch of the drug on their premises in Canada if the following conditions are met:

      • (i) the packager/labeller, distributor or importer

        • (A) has evidence satisfactory to the Director to demonstrate that drugs sold to them by the vendor of that lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for those drugs, and

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

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

  • (2) If the packager/labeller, distributor or importer receives a lot or batch of a drug on their premises in Canada the useful life of which is more than 30 days, the lot or batch shall be tested for identity and the packager/labeller shall confirm the identity after the lot or batch is packaged/labelled.

  • (3) Subsections (1) and (2) do 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 that activity.

  • (4) Subsections (1) and (2) do not apply to a distributor or importer if the drug is fabricated, packaged/labelled and tested 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.

  • SOR/82-524, s. 3;
  • SOR/89-174, s. 8(F);
  • SOR/97-12, ss. 16, 57;
  • SOR/2000-120, s. 11;
  • SOR/2002-368, s. 10;
  • SOR/2013-74, s. 11.
 
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