Food and Drug Regulations

C.04.420 (1) For each donor, the fabricator shall keep

• (a) the original or a copy of the donor’s acknowledgement and consent under paragraphs C.04.403(1)(b) and (2)(b), if any;

• (b) the original or a copy of any determinations, examinations, test results, reports and written notices made under sections C.04.401 to C.04.423;

• (c) for each specific immunization given by the fabricator to the donor, a record indicating

  • (i) the date and location of the immunization,

  • (ii) the physician or physician substitute who administered the immunogen, and

  • (iii) for the immunogen injected, its name and manufacturer’s name, the quantity and expiry date and either the immunogen’s lot number and drug identification number or, if the immunogen is red blood cells, its unique identifier;

• (d) for each plasmapheresis session held by the fabricator for the donor, a record indicating

  • (i) the date and location of the session,

  • (ii) the volume of source plasma collected,

  • (iii) the unique identifier assigned to the source plasma,

  • (iv) the volume of red blood cells collected that was not returned to the donor, including the volume of red blood cells collected during sampling,

  • (v) for the anticoagulant solution used, its name, its manufacturer’s name and its lot number and drug identification number, and

  • (vi) for the container used, the manufacturer’s name and the container’s lot number and expiry date.

(2) The fabricator shall maintain a summary of all accidents, errors, serious adverse reactions and recalls of source plasma involving the fabricator.

(3) The fabricator shall maintain temperature records made under subsection C.04.417(2).