The value of Good Manufacturing Practice to a Blood Service in managing the delivery of quality

The delivery of 'quality' in transfusion medicine is addressed by considering how safe and efficacious blood, blood components, reagents, and services can be provided through the application of an effective quality assurance management system. The creation of such a system in the UK is reviewed through the development of the UK Guide to Good Pharmaceutical Manufacturing Practice from 1971 to the present. It provides simple practical guidance and standards. The UK experience shows how quality assurance has evolved, it is not offered as a model to be followed. The UK approach merged with that of the European Union from the early 1990s. The use of such a quality management system to support the application of licensing and accreditation standards relevant to the work of a modern Blood Service is considered, as are processes to learn about the effective and efficacious use of blood and blood components.