Food and Drug Regulations

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.