Quality Assurance and Good Manufacturing Practice in Respect of Plasma Fractionation
Journal Title: Iranian Journal of Blood and Cancer - Year 2011, Vol 3, Issue 3
Abstract
The Quality centers shall build up a quality system. This comprises all activi-ties 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 selec-tion 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 estab-lishment 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. Appro-priate corrective actions should be taken. Corrective and protective actions should be documented and assessed for effectiveness after implementation.
Authors and Affiliations
Kamran Mousavi Hosseini, Zohreh Sharifi
Keywords
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