Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Close this folderSafety of blood-derived products
View the documentQuality and safety of plasma for fractionation
View the documentProcedures for inactivation and removal of viruses
View the documentGMP in blood plasma collection centres
View the documentPlasma fractionation - Brazilian programme of self-sufficiency in blood products
View the documentSafety of blood products in New Zealand
View the documentRegulatory experience in Argentina
View the documentSafety of blood products in the Islamic Republic of Iran
View the documentRecommendations
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Plasma fractionation - Brazilian programme of self-sufficiency in blood products

Dr Granville G. de Oliveira, Brazil

The national policy on blood components and blood products is required by law to aim at ensuring self-sufficiency in blood products in Brazil and at harmonizing public actions at all government levels to achieve this goal. The policy is being implemented within the scope of the United Health System, by the National System of Blood Components and Blood Products.

In 2000, there was temporary fractionating of surplus plasma for therapeutic uses. In selecting the plasma to be fractionated, a questionnaire on plasma production was sent to haemotherapy services in July 2000. Selected plasma was:

• From haemotherapy services matching the sanitary inspection reports issued by the National Programme of Inspection of Haemotherapy Units (PNIUH).

• Tested individually for all the serological markers required in legislation;

• Traceable;

• From haemotherapy services that carry out internal quality control in the serology laboratory;

• Frozen within 8 hours of blood collection;

• Stored at -30 to -18°C;

• Stored in equipment with temperature stability and control in compliance with technical standards.


In December 2000, an international invitation to bid was announced for fractionation services. Criteria for selection included: qualification of company, certification of plasma collecting services and price. Contracts were signed in December 2001. There are monthly collections of plasma by the companies delivering the service and final products are expected to be available in Brazil in June 2002.

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