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

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

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 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).

  • 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 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

  • C.02.018. (1) Each lot or batch of a drug shall, prior to its availability for sale, be tested against the specifications for that drug.

  • (2) No lot or batch of a drug shall be available 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.