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2 月前

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水是药品生产中用量 大，使用 广的重要原料，水质的优劣直接影响到药品质量，纯化水、注射用水的质量标准在美国药典24版的正文中做了明确规定，另外在其附录中也详细规定了制药用水系统的类型，水的选用，水系统的验证，安装要求、清洗和消毒及维护等。FDA检查时特别留意纯水系统，往往会花上相当的时间进行检查，我们从近年来FDA对海外检查的警告信中也可看出，许多厂家在制药用水的控制上出了问题：有些厂家由于产品生产中内毒素难以去除，需要从源头控制，由此可以看出，“药品制造过程的任何一个环节都影响到产品的质量”这一GMP思想，成为FDA对药品控制的一项基本原则。当然，药品生产质量管理是一个系统工程，准备接受FDA检验应严格按照GMP的要求进行，但是，毕竟现场检查的时间有限，而且存在语言的障碍，作好这些准备工作，无疑会对检查的顺利通大有裨益迎查注意事项：

Water is the most widely used and important raw material in drug production. The quality of water directly affects the quality of drugs. The quality standards of purified water and water for injection are clearly specified in the text of USP 24. In addition, the appendix also specifies the type of pharmaceutical water system, water selection, verification and installation requirements of water system Cleaning, disinfection and maintenance, etc. FDA pays special attention to the pure water system during inspection, which often takes a considerable time to inspect. We can also see from the FDA's warning letter on overseas inspection in recent years that many manufacturers have problems in the control of pharmaceutical water: some manufacturers need to control from the source because it is difficult to remove endotoxin in product production, "Any link in the pharmaceutical manufacturing process affects the quality of products" This GMP idea has become a basic principle of FDA's drug control. Of course, drug production quality management is a systematic project, and preparation for FDA inspection should be carried out in strict accordance with the requirements of GMP. However, after all, the time for on-site inspection is limited and there are language barriers. Making these preparations will undoubtedly be of great benefit to the smooth passage of inspection. Precautions for inspection:


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TikTok圣诞营销指南：让品牌表现得不像广告商！

作为一个娱乐平台，TikTok是让消费者充分感受到节日气氛的地方。TikTok独特的能力——即以圣诞主题趋势、挑战和内容创造一个快乐和包容的氛围，使它成为那些渴望节日气氛的用户发现产品的 …