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.