Blood Establishments are required under Directive 2005/62/EC7 to implement EC standards and specifications relating to a quality system for Blood Establishments, taking fully into account the principles of GMP. Article 2 of the Directive identifies the need for Good Practice Guidelines. These are in the process of preparation and the first iteration appears in the Council of Europe’s Guide to the Preparation, Use and Quality Assurance of Blood Components, Annex 1.17 Over the next few editions of the guide the contents of the annex will be expanded and elaborated to fully incorporate all relevant aspects of GMP. When complete, it will become the Good Practice Guidelines referred to in Article 2 of Directive 2005/62/EC.7
In the absence of a complete guide, the approach we have taken in this chapter is to outline in this section the requirements of a quality management system in the context of the collection, processing, testing, storage and distribution of blood and blood components and tissues.
In addition, Blood Establishments should ensure they are compliant with the specific standards identified within the Blood Safety and Quality Regulations 20052 and other relevant standards
and guidelines. These elements of the quality management system can be adapted to support other activities that a Blood Establishment may undertake, such as diagnostic testing and reagent production.
Blood Establishments are required to obtain a Blood Establishment Authorisation from MHRA before operating and to ensure that it is maintained through inspections scheduled every 2 years.
Hospital blood banks are required to comply with the elements of the quality system outlined below relevant to their activities (see section 2.6). In addition, they must:
These establishments should also operate a quality system that reflects the requirements below (section 2.6). The Tissues and Cells Directives are not as explicit on the requirements of a quality management system as the Blood Safety and Quality Directives and a quality system in the context of the Tissues and Cells Directives consists of the following elements: the organisational structure, defined responsibilities, procedures, processes, and resources for implementing quality management, and includes all activities which contribute to quality, directly or indirectly. Experience has shown that the elements below are effective in maintaining quality and safety in the procurement and supply of tissues and cells.