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
 

GMP in blood plasma collection centres

Dr Christian Schäerer, Switzerland

The national regulatory authority of Switzerland, Swissmedic, is responsible for the enforcement of the Federal Law on Therapeutic Products, including blood, blood components and blood products.

Controls on stable blood products are similar to those for drugs. For labile blood products, an establishment licence must have been obtained, and quality assurance and GMP ensured for all steps and all quality aspects. For blood and plasma products, specific factors that need to be considered include donor suitability, blood or plasma collection, tests to be performed, preparation, labelling and release processes, etc.

Plasma is a unique biological starting material and traceability is the key to safety. There must be an effective information system between the plasma supplier, the testing laboratory and the fractionators. GMP requirements should cover all stages leading to the finished product. In addition, blood or plasma used as source material should be collected by establishments and tested in laboratories that are subject to inspection and approval by a competent national regulatory authority.

A national regulatory authority should enforce compliance with GMP and the implementation of licensing and inspection systems for blood and plasma collection centres. The use of international standards will further promote harmonization and facilitate regional collaboration and information exchange.

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