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Food and Drug Regulations

Version of section C.02.009 from 2006-03-22 to 2018-04-03:

  •  (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 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/97-12, s. 59
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