GxP-数据完整性修订版-英国药监-2016.07.21

lmqqwer

修订版的说明：

The revised MHRAguidance builds on experience over the past 18 months; addressing some gaps inour previous guidance, and clarifying expectations where inspections have shownan unexpected interpretation of the requirements. In common with otherregulatory partners, we have cross referenced to other relevant guidance, toavoid repetition.

数据完整性实施18个月以来，之前的指南存在一些未完善的地方，在一些要求上的解释也是不尽人意，与其他监管机构一样，我们也参考了其他的指南来避免重复。

Goodmanufacturing practice stakeholders may note that the revision contains lessGMP-specific examples than the 2015 guidance. In the GxP version we have usedexamples applicable to more than one regulated area where illustration wasimportant. This also demonstrates how the principles of data governance, andthe way in which they can be implemented, can be very similar across all areasof the pharmaceutical lifecycle. This is important for organisationsparticipating in research and commercial supply to consider when reviewingrisks and control measures. Shared learning and common systems can saveresources and avoid common failures.

GMP 相关方也许会注意到这次的修订版GMP方面列举的例子会比2015的要少，在GxP版本中我们举了一些可以应用于多个需要解释的领域的例子，说明数据完整性的原则和实施的方法在药品生命周期所有领域是比较相似的，这对组织者参与研究和商业决策者在审核风险和采取措施时比较重要，有着共同系统和认知可以节省资源，避免常见的失误。

大草原制药人

学习一下。

大草原制药人

谁有翻译版呀？

lmqqwer

大草原制药人 发表于 2016-7-22 11:18
学习一下。

看慢点嘛，个别单词查一下，应该可以看懂的啊，翻译起来太费劲了

kc1711422001

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维塔斯Vitas

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liti0219

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胜利者

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windli

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qianhaorr

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古道瘦马MJ

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hgger

非常感谢分享啊！！

丁之章

不错，有没有翻译版啊

君瀹

谢谢分享

君瀹

翻译软件翻译的，随便看看还凑合，较真的话就没什么意思了。有需要的去看看吧。

qiyl2008

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201300

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helloday

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貂婵

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