The News "Detailed analysis of EMA's new Guideline on Process Validation" from March 2014 reported about EMA's revised process validation guideline entitled "Guideline on process validation for finished products - information and data to be provided in regulatory submissions". Now, the European Medicines Agency has surprinsingly published a new revision.
2014年3月的新闻“EMA新的工艺验证指南的详细分析”报道了EMA修订的工艺验证指南——制剂工艺验证指南---在法规提交中要提供的资料和数据。现在，EMA出乎意料的发布一个新的修订版。
Why this revision? What has changed?
为何进行修订？有何变化？
Beforehand, please note that the changes are marginal and characterised as "minor update" by the EMA. Solely the definition for "on-line measurement" has been incorporated into the glossary. For the EMA, this is not a complete revision and thus there will be no consultation phase.
首先，请注意这些变化是微小的，可以定性为“微小更新”。仅仅是术语表中“在线”测量的定义改变。对于EMA来说，这不是完全修订，因此不会有征求意见阶段。
For further details please refer to the "Guideline on process validation for finished products - information and data to be provided in regulatory submissions" issued on 21 November.
详情请参阅11月21日发布的“制剂工艺验证指南---在法规提交中要提供的资料和数据”。
Definition of theGlossary“On-line”：
关于“在线”的定义
2014版
Measurement where the sample is diverted from the manufacturing process and not returned to the process stream. （2014/02/27版）
样品从生产工艺转移且不返回工艺流程所进行的测试。
2016修订版
Measurement where the sample is diverted from the manufacturing process, and may be returned to the process stream. （2016/11/21版）
来源:GMP办公室
