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National Repository of Grey Literature 2 records found  Search took 0.01 seconds. 
The Quality and Safety of Transfusion Products - a Study on Critical Aspects of Quality and Important Factors in Quality Control
 Zimová, Renata ; Bláha, Milan (advisor) ; Gašová, Zdenka (referee) ; Turek, Petr (referee)
The quality and safety of transfusion products - a study on critical aspects of quality and important factors in quality control Products made from blood (transfusion products and blood derivatives) represent a special group of therapeutic preparations that have specific properties (danger of allergic reactions, transfer of infections etc.). The aim of this study was to show critical points of the process of producing safe, first-rate transfusion preparations at the level reflecting the progress in medicine and technology. Secondary aim was to analyze whether inspections of the State Institute for Drug Control, strict requirements and implementation of EU legislative have influence on the quality of work in blood establishments (BEs) and whether there are some relations between selected BEs with similar characteristics (the size and type of facility) and quality of work as this is presently a heated topic in discussions about restructuralization of transfusion service. The author analyzed her own experience gained during 129 inspections from the view of Good Manufacturing Practice (GMP) in BEs in the Czech Republic and abroad. The survey of results The most frequent and most important shortcomings (key and critical points) in production of transfusion products are parameters described in the chapter...
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The Quality and Safety of Transfusion Products - a Study on Critical Aspects of Quality and Important Factors in Quality Control
 Zimová, Renata ; Bláha, Milan (advisor) ; Gašová, Zdenka (referee) ; Turek, Petr (referee)
The quality and safety of transfusion products - a study on critical aspects of quality and important factors in quality control Products made from blood (transfusion products and blood derivatives) represent a special group of therapeutic preparations that have specific properties (danger of allergic reactions, transfer of infections etc.). The aim of this study was to show critical points of the process of producing safe, first-rate transfusion preparations at the level reflecting the progress in medicine and technology. Secondary aim was to analyze whether inspections of the State Institute for Drug Control, strict requirements and implementation of EU legislative have influence on the quality of work in blood establishments (BEs) and whether there are some relations between selected BEs with similar characteristics (the size and type of facility) and quality of work as this is presently a heated topic in discussions about restructuralization of transfusion service. The author analyzed her own experience gained during 129 inspections from the view of Good Manufacturing Practice (GMP) in BEs in the Czech Republic and abroad. The survey of results The most frequent and most important shortcomings (key and critical points) in production of transfusion products are parameters described in the chapter...
Detailed record

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1 Zimová, Radka
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