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

Regulations are current to 2021-06-28 and last amended on 2021-06-23. Previous Versions

PART CDrugs (continued)

DIVISION 2Good Manufacturing Practices (continued)

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 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.

  • SOR/82-524, s. 3
  • SOR/89-174, s. 8(F)
  • SOR/2018-69, s. 27
  •  (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.

  • SOR/82-524, s. 3
  • SOR/89-174, ss. 2(F), 8(F)
  • SOR/97-12, s. 56(F)
  • SOR/2018-69, s. 27

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 Minister 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 Minister, 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 they retain a copy of the batch certificate for each lot or batch of the drug that they receive.

  • (5) Subsections (1) and (2) do not apply to a distributor or importer of a drug that is not a prescription drug and that is part of a class of drugs that is set out in column 1 of the List of Non-prescription Drugs Not Subject to Certain Testing Requirements if all of the following conditions are met:

    • (a) the drug contains, as its only active ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6;

    • (b) the drug is

      • (i) fabricated in Canada or in a recognized country or region,

      • (ii) packaged/labelled in Canada or in a recognized country or region, and

      • (iii) tested in a recognized country or region;

    • (c) the distributor or the importer retains a copy of the batch certificate for each lot or batch of the drug that is distributed or imported, as the case may be.

  • (6) A drug that is referred to in subsection (5) may be shipped directly to a person other than an importer if all of the following conditions are met:

    • (a) before importing the drug, the importer receives a document that demonstrates that the drug complies with the specifications for that drug;

    • (b) the importer and the distributor have measures in place to ensure that all the requirements of these Regulations in respect of the importation of the drug are met.

  • 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
  • SOR/2018-69, s. 27
  • SOR/2020-73, s. 2

Records

  •  (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall maintain all of the following records on their premises in Canada for each drug that they fabricate, package/label, distribute or import:

    • (a) except in the case of an importer of an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act, master production documents for the drug;

    • (b) evidence that each lot or batch of the drug has been fabricated, packaged/labelled, tested and stored in accordance with the procedures described in the master production documents;

    • (c) evidence that the conditions under which the drug was fabricated, packaged/labelled, tested and stored are in compliance with the requirements of this Division;

    • (d) evidence that establishes the period during which the drug in the container in which it is sold or made available for further use in fabrication will meet the specifications for that drug; and

    • (e) evidence that the finished product testing referred to in section C.02.018 was carried out and the results of that testing.

  • (2) Every distributor referred to in paragraph C.01A.003(b) and importer shall make available to the Minister, on request, the results of testing performed on raw materials and packaging/labelling materials for each lot or batch of a drug that it distributes or imports.

  • (3) Every fabricator shall maintain on their premises written specifications for all raw materials and adequate evidence of the testing of those raw materials referred to in section C.02.009 and of the test results.

  • (4) Every person who packages a drug shall maintain on their premises written specifications for all packaging materials and adequate evidence of the examination or testing of those materials referred to in section C.02.016 and of any test results.

  • (5) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada detailed plans and specifications of each building in Canada where they fabricate, package/label or test drugs and a description of the design and construction of those buildings.

  • (6) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada personnel records in respect of each person who is employed to supervise the fabrication, packaging/labelling and testing of drugs, including the person’s title, responsibilities, qualifications, experience and training.

  • SOR/82-524, s. 3
  • SOR/89-174, ss. 3(F), 8(F)
  • SOR/97-12, ss. 17, 52, 60
  • SOR/2013-74, s. 11
  • SOR/2017-259, s. 15
  • SOR/2018-69, s. 27
 
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