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标题: 欧盟GMP更新第六章：质量控制 [打印本页]

作者: 北京-丹丹 时间: 2014-4-11 09:56 AM
标题: 欧盟GMP更新第六章：质量控制

欧盟理事会于2014年4月3日，发布其更新后的GMP第6章——质量控制。一段公示期后，此版本将在2005年替换旧版本。总的来说，此次更新还是蛮大的，最主要的改变，是加入了检验方法的技术转移，并整合进了OOS和趋势分析等内容：

the transferring site should verify that the test methods comply withthe marketing authorization or the relevant technical dossier

方法转移单位应该注意法规符合性

the original validation of the test method should be compliant withcurrent ICH/VICH requirements 方法验证符合ICH要求

a gap analysis should be performed and documented prior to commencingthe technical transfer process

技术转移前进行差距分析

a detailed transfer protocol should be compiled and at least include:

建立方法转移方案

the relevant test methods, any additional training requirements,standards and samples to be tested by both, the transferring and the receivinglaboratory, special transport and storage conditions required for the testitems.

方案中应规定的内容

deviations from the protocol should be investigated prior to closure ofthe technical transfer process in order to identify areas requiring furthertest method revalidation.

对方案偏差进行调查，以确定是否再验证

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