Food and Drug Regulations
C.04.425 If pilot samples of human plasma are provided, they shall meet the following standards:
(a) prior to filling, all containers of pilot samples shall be marked or labelled so as to relate them directly to the donor of that unit of plasma;
(b) all containers of pilot samples shall be filled at the time the final product is prepared by the person who prepares the final product;
(c) all pilot samples shall be representative of the contents of the final product; and
(d) all pilot samples shall be collected in a manner that does not contaminate the contents of the container.
- SOR/78-545, s. 1
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