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

C.02.013. (1) Every fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall have on their premises in Canada a quality control department that is supervised by personnel described in section C.02.006.

(2) Except in the case of a wholesaler, the quality control department shall be a distinct organizational unit that functions and reports to management independently of any other functional unit, including the manufacturing, processing, packaging or sales unit.

C.02.014. (1) Except in the case of a wholesaler, no lot or batch of a drug shall be made available for sale unless the sale of that lot or batch is approved by the person in charge of the quality control department.

(2) A drug that is returned to the fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) or importer shall not be made available for further sale unless the sale of that drug is approved by the person in charge of the quality control department.

(3) No lot or batch of raw material or of packaging/labelling material shall be used in the fabrication or packaging/labelling of a drug unless the material is approved for that use by the person in charge of the quality control department.

(4) No lot or batch of a drug shall be reprocessed without the approval of the person in charge of the quality control department.

C.02.015. (1) All fabrication, packaging/labelling, testing, storage and transportation methods and procedures that may affect the quality of a drug shall be examined and approved by the person in charge of the quality control department before their implementation.

(2) The person in charge of the quality control department shall cause to be investigated any complaint or information that is received respecting the quality of a drug or its deficiencies or hazards and cause any necessary corrective action to be taken, in the case where the complaint or information relates to an activity over which the department exercises quality control.

(2.1) In the case where the complaint or information that is received does not relate to an activity over which the quality control department exercises quality control, the person in charge of the department shall forward the complaint or information to the person in charge of the quality control department that exercises quality control over that activity.

(3) The person in charge of the quality control department shall cause all tests or examinations required pursuant to this Division to be performed by a competent laboratory.