The_GMPs nobel chinese.ppt

The GMPs 药品生产质量管理规范 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS 药品生产、加工、包装和贮存的现行GMP Presented by Bill Mehl 演讲人：彼尔 枚尔 The GMPs (a) The regulations set forth in this part and in Parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. 本部分以及本章第211～226部分包括了药品生产、加工、包装和贮存所用方法的必要GMP法规，以确保药品达到法案规定的安全性要求，且其性质和浓度达到其宣称或应该达到的质量和纯度。 What Does This Mean?含义 This is the law that gives FDA most of its power. 这项法律的大部分权利由FDA执行。 The important thing is that these are the minimum required. 重要的是这些法规是最低要求。 How these are met is the problem, FDA can interpret the minimum in many ways. 如何达到这些法规是一个问题，FDA可以有很多方式诠释“最低”。 § 210.1 Status of current good manufacturing practice regulations.现行GMP法规状况 (b) The failure to comply with any regulation set forth in this part and in Parts 211 through 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action. 如果一个药品没有达到本部分以及本章第211～226部分下药品生产、加工、包装和贮存的法规，这个药品将会归于方案第501(a)(2)(B) 部分下的不合格品，而且将会对为此不合格负责的人采取法律行动。 What Does This Mean?含义 FDA does not have to prove there is something wrong with your drug. FDA不需要证明你的药品有问题。 Your drug is assumed to have something wrong if your not meeting the GMPs 如果你没有达到GMPs，就会认为你的药品有问题。 For foreign firms it is easy for FDA to deal with your product. They issue a