Importance of documentation in GMP

Abstract

The international Society of Blood Transfusion, in conjunction with the American Association of Blood Banks, the American Red Cross and the Canadian Blood Services, has submitted a proposal to the World Health Organisation (WHO) to have whole blood and red cells included on the WHO List of Essential Medicines. If this is implemented, compliance with Good Manufacturing Practice (GMP) in the preparation of blood components will be paramount for all blood establishments in the world. Documentation plays a role in all aspects of GMP and an efficient document control system is crucial in ensuring blood products are consistently produced to the appropriate quality standards. This ultimately leads to enhanced patient safety.