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

C.04.418. (1) A fabricator shall inspect each container of source plasma to determine if the container and its label are intact and if there are any indications that the source plasma has been subject to thawing.

(2) The fabricator shall dispose of the source plasma if the inspection shows that

• (a) the container is defective or damaged to the extent that it does not provide protection against external factors that could result in deterioration or contamination of the source plasma;

• (b) the unique identifier assigned to the source plasma is missing or illegible;

• (c) any information required under paragraphs C.04.416(2)(b) to (i) is missing or illegible, unless the missing or illegible information can be retrieved from the fabricator’s records; or

• (d) the source plasma has been subject to thawing.

C.04.419. (1) A fabricator shall use and maintain a recordkeeping system according to which the fabricator shall

• (a) assign a personal identifier to each donor;

• (b) keep on the donor’s file a photograph of the donor or some other reliable means of identification; and

• (c) assign a unique identifier to the source plasma collected by the fabricator at each plasmapheresis session.

(2) The system shall be structured so that a fabricator may, based on a personal identifier or a unique identifier, identify the donor and retrieve sufficient records to permit the traceability and recall of source plasma.

(3) The fabricator shall keep the records referred to in subsection (2) indefinitely.

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).