To ensure a quality assurance system (QAS) in haemapheresis according to the rules
of current good manufacturing practice (cGMP), a total process control (TPC) should
be established [
1
]. TPC includes the day-to-day part of a QAS that involves everyone in manufacturing,
packaging, collection, storage, testing and checking of blood products. TPC should
be described in a quality assurance manual (QAM). QAM describes the organisation and
products provided, gives an overview of the facilities used in the manufacturing,
processing or delivery of services and summarises the equipment qualification process.
Documentation systems should be found throughout all areas of an organisation with
the ubiquitous standard operation procedures (SOPs) at the heart of the TPC. This
paper focuses on relevant SOPs, audits and training in haemapheresis.To read this article in full you will need to make a payment
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References
The Rules governing Medicinal Products in the European Community, Vol IV: Guide to Good Manufacturing Practice for Medicinal Products.; Office for Official Publications of the European Communities, Luxenburg.
Guide to the preparation, use and quality assurance of blood components. Council of Europe Press, 1995, Strasbourg.
Article info
Publication history
Accepted:
November 1,
1998
Received:
September 11,
1998
Identification
Copyright
© 1999 Elsevier Science Ltd. Published by Elsevier Inc. All rights reserved.
