分享——QBD新法规

清歌一曲月如霜

QBD新法规

The Quality by Design(QbD) concept has been introduced by the International Conference onHarmonisation (ICH) document Q8, supported by Q9, Q10 and also Q11. Inthe meantime it is well-known within the pharmaceutical industry. However manycompanies still struggle with the implementation. Both the European MedicineAgency (EMA) and the U.S. Food and Drug Agency (FDA) are supporting thepharmaceutical industry in the employment of the paradigm. Now, EMA and FDAhave published a second joint question-and-ans*******ument that providesfurther guidance on the quality-by-design concept.

The new document focuseson 'design space verification' and reflects conclusions reached in the on-goingparallel assessment, which was launched in 2011. The objective of the parallelassessment is to share knowledge, facilitate a consistent implementation of theinternational guidelines on the implementation of the quality-by-design conceptand promote the availability of medicines of consistent quality throughout theEuropean Union (EU) and the USA.

The EMA and the US FDAwill publish further conclusions on other quality-by-design-related topics asthe pilot programme continues and more parallel assessments are conducted.


质量源于设计（QbD ）理念已引入国际会议（ICH） onHarmonisation文件Q8 ， Q9 ， Q10和Q11支持。在此期间，它是众所周知的医药行业内。然而manycompanies仍然奋斗的实施。无论是欧洲MedicineAgency （EMA）和美国食品和药品监督局（ FDA ）支持thepharmaceutical行业在范式就业。现在， EMA和FDAhave发表了第二次联席会议的问题和答******* UMENT providesfurther指导对设计质量的概念。

的新文档focuseson设计空间验证，并反映在上goingparallel的评估，于2011年推出的结论。的parallelassessment的目标是分享知识，促进促进整个theEuropean联盟（欧盟）和美国药品质量稳定的可用性设计质量conceptand实施的“国际肥胖指引的贯彻实施。

EMA和美国FDAwill的其他设计质量相关的话题继续asthe试点方案公布进一步的结论，并进行更多的并行评估。

蒸蒸日上路人亿

我第一个，{:soso_e113:}抢沙发!

yuansoul

软件翻译不得取
人工转换或不知
遵守法规喝绿茶
置若罔闻越霜如

胜利者

谢谢分享

中华骏捷

看不懂。

兮兮

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最爱花衬衫

谢谢分享！

前夜传说

谢谢楼主分享

hoogle

无法打开啊！！！！

hoogle

下载不了！！

gproe

好好学习天天向上