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

C.02.005. The equipment with which a lot or batch of a drug is fabricated, packaged/labelled or tested shall be designed, constructed, maintained, operated and arranged in a manner that

• (a) permits the effective cleaning of its surfaces;

• (b) prevents the contamination of the drug and the addition of extraneous material to the drug; and

• (c) permits it to function in accordance with its intended use.

C.02.006. Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic and other training as the Director considers satisfactory in the interests of the health of the consumer or purchaser.

• C.02.007. (1) Every person who fabricates or packages/labels a drug shall have a written sanitation program that shall be implemented under the supervision of qualified personnel.

• (2) The sanitation program referred to in subsection (1) shall include

  • (a) cleaning procedures for the premises where the drug is fabricated or packaged/labelled and for the equipment used in the fabrication or packaging/labelling; and

  • (b) instructions on the sanitary fabrication and packaging/labelling of drugs and the handling of materials used in the fabrication and packaging/labelling of drugs.

• C.02.008. (1) Every person who fabricates or packages/labels a drug shall have, in writing, minimum requirements for the health and the hygienic behaviour and clothing of personnel to ensure the clean and sanitary fabrication and packaging/labelling of the drug.

• (2) No person shall have access to any area where a drug is exposed during its fabrication or packaging/labelling if the person

  • (a) is affected with or is a carrier of a disease in a communicable form; or

  • (b) has an open lesion on any exposed surface of the body.

• 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.