Food and Drug Regulations

Version of section C.04.419 from 2006-12-14 to 2014-10-22:

  •  (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.

  • SOR/78-545, s. 1;
  • SOR/85-1022, s. 9;
  • SOR/2006-353, s. 1.
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