PIC/S GMP Guide for Blood Establishments
PE 005-2
Overview
Blood components are often used in life threatening situations of severely ill patients. Allied to this is a heightened public awareness and expectation of the quality and safety of these products. Therefore, high standards of quality and
safety of blood components have to be assured. These high standards can only be achieved by applying the principles of GMP during the collection, preparation, storage, dispatch, quality control and quality assurance of these products.
The purpose of this document is to provide guidance for GMP-inspectors to use during inspections of blood establishments. However, the document does also give an insight into the thinking and concerns of inspectorates and so could provide some useful information for blood establishments relating to the collection, preparation, storage, dispatch, quality control and quality assurance of blood and blood components.
At the time of issue this document reflects the current state of the art. It is not intended be a barrier to technical innovation or the pursuit of excellence. However, applicable national legislation should always be referred to whendetermining the extent to which the provisions laid down in this document are binding. This document should be used for PIC/S related inspections. This document applies to blood and apheresis establishments relating to the collection, preparation, storage, dispatch, quality control and quality assurance of human blood and blood components. This document does not apply to human blood and plasma when collected and tested for the sole purpose and exclusive use as the starting material for the manufacture of medicinal products which are prepared industrially by public or
private establishments.