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 all of the following records on their premises in Canada for each drug that they fabricate, package/label, distribute or import:

• (a) except in the case of an importer of an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act, 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 that establishes the period during which the drug in the container in which it is sold or made available for further use in fabrication will meet the specifications for that drug; and

• (e) evidence that the finished product testing referred to in section C.02.018 was carried out and the results of that testing.

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

(3) Every fabricator shall maintain on their premises written specifications for all raw materials and adequate evidence of the testing of those raw materials referred to in section C.02.009 and of the test results.

(4) Every person who packages a drug shall maintain on their premises written specifications for all packaging materials and adequate evidence of the examination or testing of those materials referred to in section C.02.016 and of any test results.

(5) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada detailed plans and specifications of each building in Canada where they fabricate, package/label or test drugs and a description of the design and construction of those buildings.

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