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WHO-GMP补充指南:验证(中英对照)
来源:网络
Validation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance programme associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use. These principles are as follows:
验证是药品生产管理规范(GMP)的一个重要组成部分;也正因如此,所以它同时也是产品或工艺的质量保证计划的一个不可或缺的要素。质量保证的基本原则以生产出符合设计用途的产品为目的,它的主要内容为:
Quality, safety and efficacy must be designed and built into the product.
要事先设计质量、安全和效力,并使之在产品中实现。
Quality cannot be inspected or tested into the product.
不能仅仅只考察和检验成品的质量。
Each critical step of the manufacturing process must be validated. Other steps in the process must be under control to maximize the probability that the finished product consistently and predictably meets all quality and design specifications.
生产工艺的每一关键步骤都必须经过验证,非关键步骤也必须得到控制,从而实现在最大程度上生产出符合全部质量和既定标准的产品的目的。
WHO-GMP补充指南:验证(中英对照).pdf
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