Quality Assurance and Good Manufacturing Practice in Respect of Plasma Fractionation

The Quality centers shall build up a quality system. This comprises all activities in the blood center intended to ensure that all blood and all components have a quality corresponding to the intended use.Quality Assurance shall cover all aspects of manufacture starting with selection of donors, blood bags, anticoagulant solutions and including collection, storage, transportation, processing, quality control and delivery of the finished component. Good Manufacturing Practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. Good manufacturing Practice is concerned with production and quality control.In order to monitor the implementation and compliance with the blood establishment quality management system, regular internal audits need to be in place. These should be conducted independently by trained and competent persons from within the organization, according to approved protocols.All audits results should be documented and reported to management. Appropriate corrective actions should be taken. Corrective and protective actions should be documented and assessed for effectiveness after implementation.