Food and Drug Regulations
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 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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