Regulatory control of blood products in Canada. NLM AIDSLINE Important note: Information in this article was accurate in 1987. The state of the art may have changed since the publication date.

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Regulatory control of blood products in Canada.

Dev Biol Stand. 1987;67:221-8. Unique Identifier : AIDSLINE MED/87276910
Boucher DW; Furesz J

Abstract: Blood products are considered as biological drugs in Canada and are regulated under The Food and Drugs Act. Before a biological drug may be sold, the manufacturer must file a new drug submission with the Bureau of Biologics and receive a notice that the submission complies with the regulations. In addition the manufacturer must comply with the requirements for a license, including the detailed description of manufacturing facilities, qualifications of personnel, and standard operating procedures of all manufacturing steps. To verify the information provided by the manufacturer, senior scientists of the Bureau conduct an inspection of the manufacturing premises. In order to ensure the safety and potency of the product, the Bureau authorizes the sale of the product on a lot by lot basis. Samples of each lot are submitted to the Bureau laboratories for testing. In November 1984 the Bureau required manufacturers to treat coagulation products by a method proven to inactivate HTLV-III/LAV. While immune globulin preparations have not been associated with virus transmission in recipients, the Bureau tested 22 lots of various immune globulin products for HTLV-III/LAV antibodies. Using the Western Blot assay 9 lots were found antibody positive. Although these lots are not considered infectious, further studies are required from manufacturers to demonstrate by virus isolation attempts and virus spiking studies that the fractionation procedure eliminates potentially infectious virus.
Keywords: Acquired Immunodeficiency Syndrome/BLOOD/PREVENTION & CONTROL/ TRANSMISSION Blood Proteins/*STANDARDS Canada Human *Legislation, Pharmacy *Licensure, Pharmacy Quality Control JOURNAL ARTICLE

KWDacquiredimmunodeficiencysyndrome/blood/prevention&control/transmissionbloodproteins/KWDstandardscanadahumanKWDlegislation,pharmacyKWDlicensure,pharmacyqualitycontroljournalarticle
871130
M87B0366

Copyright © 1987 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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