Regulation of Blood Components - a Help or Hindrance to Good Clinical Practice?

Abstract

The application of formal regulatory structures to the field of blood component and blood product manufacture is an understandable response to public and governmental concern over the safety of such products. Internationally the trend is to greater central control of blood service provision and regulation is one of several tools used to achieve this. In both Australia and New Zealand, blood components are treated as medicinal products for the purposes of regulation. The imminent creation of a TransTasman Regulatory Authority provides an opportunity to review systems used for the regulation of these products within Australasia and to ensure that an appropriate balance between clinical need and quality conformance is achieved. The control of human derived medicinal products presents a number of specific challenges. This is particularly the case in relation to blood components where biological variation will impact on the ‘formulation’ of any given product. Essentially each component becomes a unique batch. Efforts at control and regulation should recognise this. Two broad approaches can be used for regulation. In the first control is achieved through the application of standard processes. In the second the necessary outcome is defined but the process not formally defined. Increasingly regulatory control of blood component manufacture favours control of the process. Control through process can however ultimately restrict clinical flexibility and responsiveness. Care must be taken to ensure that this is recognised and addressed in the development of systems utilised to assure the quality and safety of blood components.