Food and Drug Regulations

C.02.020 (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall maintain on their premises in Canada, for each drug sold,

• (a) master production documents for the drug;

• (b) evidence that each lot or batch of the drug has been fabricated, packaged/labelled, tested and stored in accordance with the procedures described in the master production documents;

• (c) evidence that the conditions under which the drug was fabricated, packaged/labelled, tested and stored are in compliance with the requirements of this Division;

• (d) evidence establishing the period of time during which the drug in the container in which it is sold will meet the specifications for that drug; and

• (e) adequate evidence of the testing referred to in section C.02.018.

(2) Every distributor referred to in paragraph C.01A.003(b) and importer shall make available to the Director, on request, the results of testing performed on raw materials and packaging/labelling material for each lot or batch of a drug sold.

(3) Every fabricator shall maintain on his premises

• (a) the written specifications for the raw material; and

• (b) adequate evidence of the testing of the raw materials referred to in section C.02.009.

(4) Every person who packages a drug shall maintain on his premises

• (a) the written specifications for the packaging material; and

• (b) adequate evidence of the packaging material examination or testing referred to in section C.02.016.

(5) Every fabricator shall maintain on their premises in Canada

• (a) detailed plans and specifications of each building in Canada at which they fabricate, package/label or test; and

• (b) a description of the design and construction of those buildings.

(6) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada details of the personnel employed to supervise the fabrication, packaging/labelling and testing, including each person’s title, responsibilities, qualifications, experience and training.