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本帖最后由 julia朱玉姣 于 2016-12-8 01:28 编辑
EMArevises Process Validation Guideline EMA修订了工艺验证指南 The News"Detailed analysis of EMA's new Guideline on Process Validation"from March 2014 reported about EMA's revised process validation guidelineentitled "Guideline on process validation for finished products -information and data to be provided in regulatory submissions". Now, theEuropean Medicines Agency has surprinsingly published a new revision. 2014年3月新闻“EMA新工艺验证指南详细分析”曾经报道过EMA题为“制剂工艺验证指南---法规申报中要提交的信息和数据”。现在EMA令人惊讶地发布一份新的修订版。 Whythis revision? What has changed?
为什么会有这次修订？修改了什么内容？
Beforehand,please note that the changes are marginal and characterised as "minorupdate" by the EMA. Solely the definition for "on-linemeasurement" has been incorporated into the glossary. For the EMA, this isnot a complete revision and thus there will be no consultation phase.
首先请注意这些修订是不重要的，EMA将其定性为“略有更新”。仅仅是将术语中定义“在线测量”进行了修订。对于EMA来说，这并不是一次全面的修订，因此没有征求意见的阶段。
Forfurther details please refer to the "Guideline on process validation for finished products -information and data to be provided in regulatory submissions" issuedon 21 November.
详细信息参见11月21日发布的“制剂工艺验证指南—法规申报中需要提交的信息和数据”。
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