Stahl D, Kluge A, Roelcke D
Institut für Immunologie, Ruprecht-Karls-Universität, Heidelberg, Deutschland.
Beitr Infusionsther Transfusionsmed. 1996;33:247-56.
The 'Pharmabetriebsverordnung' requires a quality assurance system for the manufacturing of blood products. The quality assurance system of the university blood bank at Heidelberg is founded on the components 'quality of structure', 'quality of process' and 'quality of result'. The internal quality standard, based on national law and national/international guidelines, is specified in written form for every aspect of structure, process and result by standard operating procedures (SOPs). The SOPs are the basis for the quality system manual and the laboratory reference books. The quality assurance system integrates a programme for carrying out internal quality audits as well as a concept for updating SOPs at regular intervals.
《药品经营条例》要求建立血液制品生产的质量保证体系。海德堡大学血库的质量保证体系基于“结构质量”、“过程质量”和“结果质量”这些要素。内部质量标准以国家法律和国家/国际准则为依据，通过标准操作规程（SOP）以书面形式针对结构、过程和结果的各个方面予以明确规定。这些SOP是质量体系手册和实验室参考书的基础。质量保证体系整合了一个内部质量审核实施计划以及一个定期更新SOP的理念。
