章药品生产管理详解.pptVIP

Sketch of all institutions about pharmaceutical affairs 广义：A system of personnel and institutions of pharmaceutical affairs, and they relationship and influence of each other The mode of organizing, the system of administration and the method of management about pharmaceutical in a given regime. It is a system about how to divide the authority of each pharmaceutical affair institutions 三、GMP的内容 （五） 《GMP》中对厂房和设施 (1)厂房应按生产工艺流程及所要求的空气清洁级别进行合 理布局。(洁净室区空气洁净度划分为四个级别，即100级； 10 000级；100 000级；300 000级)。 (2)生产区和储存区应有与生产规模相适应的面积和空间， 应最大限度减少差错和交叉污染。 三、GMP的内容 （3）最终灭菌药品生产环境的空气洁净级别要求： ①100 级：