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FDA有关药检所检查的指南1 引言在药品生产和管理过程中,药检所起了最重要的职责。《现行药品生产质量管理规范》中最重要的一部分与质控机构和产品测试有关。原料药的情况与此类似。本检查指南增扑了包含在其他机构检查指南文件中与检查有关的资料。比如,要求对新...
FDA Guidance on Drug Control Inspection 1 Introduction Drug control plays the most important role in drug production and management. The most important part of the current “Code of Practice for the Quality of Pharmaceutical Production” is related to quality control agencies and product testing. The situation with APIs is similar. The inspection guide contains information about the inspections contained in the inspection guide documents of other institutions. For example, asking for new ...