Wagstaff W
National Blood Service, Leeds, UK.
Vox Sang. 1998;74 Suppl 2:513-21. doi: 10.1111/j.1423-0410.1998.tb05467.x.
The principles of Good Manufacturing Practice have, in the main, been universally developed for the guidance of the pharmaceutical industry rather than for transfusion services. However, these rules and guides are increasingly being adapted for use in blood centres, in the production of labile blood components and of plasma for fractionation. The guide for pharmaceutical industries produced by the commission of the European Communities is used as a model here, the nine basic requirements being those applicable to Quality Management, personnel, premises and equipment, document, production, Quality Control, contract manufacture and analysis, complaints and product recall, and self-inspection. Though having more direct application to the production laboratory preparing blood components, the majority of these requirements and principles are also directly applicable to all of the activities involved in blood collection.
药品生产质量管理规范的原则主要是为指导制药行业而普遍制定的，而非用于输血服务。然而，这些规则和指南正越来越多地被改编用于血站，用于生产不稳定的血液成分和用于分离的血浆。这里以欧洲共同体委员会制定的制药行业指南为蓝本，九个基本要求适用于质量管理、人员、厂房和设备、文件、生产、质量控制、合同生产与分析、投诉与产品召回以及自检。尽管这些要求和原则大多更直接适用于制备血液成分的生产实验室，但其中大多数也直接适用于采血过程涉及的所有活动。
