Good manufacture practice controls in blood banks

Overview

Good Manufacture Practice (GMP) requirements implemented in the legislation in CR are mandatory also for blood banks. State Institute for Drug Control performed the inspections of GMP compliance in 51 health care institutions with blood bank in 2005–2007. Many deficiencies in personal work, the premises and equipment management, documentation, storage and transport of blood components, pretransfusion immunohaematologic testing, contract management and complaints and recalling of blood components were found out. The cause of deficiencies can be process rigidity, insufficient information process, and also reluctance of health care institution management to invest in blood bank activity. Recommendations or standards are missing in CR. Recent Law 378/2007 Sb. brings new requirements for blood banks. It can be assumed removing most of deficiencies in following SUKL inspections and an implementation of new legislation requirements will be proceeded more flexibly and responsibly then up to now. The further development probably will induce larger centralisation of blood banks.

Key words:
blood bank, State Institute for Drug Control, good manufacturing practice, legislation