IG购买 海关刚刚发布了5种免费的方式，用以推广4月出口公司的奇葩事儿。

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水是药品生产中重要的原料，用量大，使用广泛。水质的好坏直接影响到药品的质量。美国药典24版在正文中明确规定了纯化水和注射用水的质量标准，在附录中还详细规定了制药用水系统的类型、选用、验证、安装要求、清洗和消毒以及维护等方面。FDA在检查中特别关注纯水系统，通常会花费相当长的时间进行检查。从近年来FDA对海外检查的警告信中也可以看出，许多制药厂家在药品用水的控制方面存在问题。由此可见，“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检验时必须严格按照GMP要求进行。然而，现场检查的时间有限，而且可能存在语言障碍，因此做好这些准备工作无疑会对检查的顺利进行大有裨益。请注意以下事项：

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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公司的那些奇葩事儿

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开年到公司上班，就听说老板会再雇佣一两个业务员的，等了快半个月，来了个女的，据说是有5-6年的工作经验。说到有经验的业务员，这是我极力推荐老板要找的，因为我自己没有工作经验，对外贸这一行什么都不懂，所以我天真的以为老板找有经验的来公司，到时候就可以带着我们进入外贸这一轨道，可事实呢？ …