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jueves, 20 de julio de 2017
Guidelines on viral inactivation of human blood plasma products
The present WHO Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products were developed to complement the WHO Requirements for the collection, processing and quality control of blood, blood components and plasma derivatives”(1), in response to the above requests.
These Guidelines pertain to the validation and assessment of the steps for viral inactivation and removal employed in the manufacture of human blood plasma derivatives and virally inactivated plasma for transfusion, prepared either from plasma pools or from individual donations.It is hoped that this document, by summarizing current experience with well recognized methods, will help set expectations, serve as a guide to speed implementation, and ensure that implementation is appropriate.
Inevitably, individual countries may formulate different policies, not only in relation to procedures for validation and control, but also regarding donor selection and methods of blood screening. These Guidelines do not replace the requirements of regulatory authorities in various parts of the world (2–4); rather, they are primarily intended to assist those national regulatory authorities and manufacturers that are less familiar with viral decontamination processes.
The document does not address products of animal origin or those manufactured by recombinant techniques.
Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. World Health Organization, WHO Technical Report, Series No. 924, 2004.
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Publicado por Julietta Torres