ongoing和continuous process verification

一沙一叶

Ongoing Process Verification (also known as continued process verification)
Documented evidence that the process remains in a state of control during commercial
manufacture.
文件化的证据证明商业生产中工艺处于控制状态，有翻译称持续工艺确认
Continuous process verification
An alternative approach to process validation in which manufacturing process
performance is continuously monitored and evaluated.
工艺验证的一种可选方法，连续的监控和评价生产工艺性能，有翻译称连续工艺确认。

也请教了一个外国注明公司的资深质量人员，他说，二者是近义词，没有什么区别。

我理解，验证不是一次就能完成的行为，尽管初次验证需要进行三次，以后还要持续监控验证中确认的关键质量属性和工艺参数，这些质量属性和工艺参数有的就是生产检验工艺的一部分，如果不是的话，可能需要进行一些验证才有的行为。至于周期，就要风险评估了。

岁寒三友

验证状态应该持续保持

yuansoul

那我就来秒一下资深质量人员。。。别告诉我是郭嘉局的


ongoing指的是持续不断的状态，没有明显间断或间隔。例如：持续心电监护。

continuous指的是持续状态，有明显间断和间隔。例如：持续治疗，可能更换药品、输液方式等。。。但是一直在治疗

作为专有词汇，Ongoing Process Verification 或者Continuous process verification 都强调过程反复确认、查证、回顾分析。

而Ongoing Process Verification 基于风险分析嵌入式一个维度概念，也就是，风险分析无处不在，是一个概念、方式、技巧，并且是粘联验证、偏差、趋势分析。。。。之间的融合（就像量子物理的时间维度）。基本属于：武当派

Continuous process verification基于前一段的质量源于设计也好；源于xx主义也好。。。。。也就是，强调了验证是一个连续过程，虽然存在间断、间隔、暂缓、停滞。。。。。就像。。。。。阿门。基本属于：嵩山派

wangjin1023

分析有道理

一沙一叶

yuansoul 发表于 2014-3-2 07:26
那我就来秒一下资深质量人员。。。别告诉我是郭嘉局的

我咨询过PDA协会主席，还有一个也是有二十多年工作经验的美国人。他们认为纠结字面意思没有必要，两个词之间也没有什么区别。

yuansoul

一沙一叶 发表于 2014-3-2 08:14
我咨询过PDA协会主席，还有一个也是有二十多年工作经验的美国人。他们认为纠结字面意思没有必要，两个词之 ...

英国女王认为：这个世界上只有英语和说错的英语

一沙一叶

yuansoul 发表于 2014-3-2 08:16
英国女王认为：这个世界上只有英语和说错的英语

像欧盟这样用了这么近的两个词，是在为难外国人啊

yuansoul

一沙一叶 发表于 2014-3-2 08:31
像欧盟这样用了这么近的两个词，是在为难外国人啊

幸亏他们没有龙族的多音字。要不然就死定了

syhorchid

学习一下

glm1024

一沙一叶 发表于 2014-3-2 08:14
我咨询过PDA协会主席，还有一个也是有二十多年工作经验的美国人。他们认为纠结字面意思没有必要，两个词 ...

我用PDA原文来打PDA协会主席的脸，原文如下：
The FDA three -stage process validation lifecycle nomenclature (Stage 1-Process Design, Stage 2– Process
Qualification, and Stage 3 –Continued Process Verification) is used i n this TR. Implementation of  these
stages is discussed in detail in  Sections 3–5. It should be noted that Continued Process Verification  and
Continuous Process Verification are distinct terms and have different meanings. Continuous  Process
Verification refers to validating manufacturing processes that utilize advanced manufacturing  and
analytical technologies (e.g., PAT systems). FDA uses the term Continued Process Verification   generally to
mean those activities which maintain the process in a state of cont rol and encompasses   all manufacturing
scenarios, i.e., traditional manufacturing, manufacturing employing advanced technologies   of any kind or
any combination thereof.
摘自  PDA TR60

60ke

以下是欧盟附录15的项目负责人关于这两个词的内容。全文见附件。意思就是说这两个没什么区别。
Ongoing process verification is something new that has been introduced to EU GMP. Traditionally in the past, companies would maybe repeat the process validation based on a time interval. Five years was common. Some might repeat the whole process validation. Some might do an assessment. So they may look at the data and then decide if the need to do a process validation or not. So there were lots of approaches previously.
Now we are saying that it needs to be done for all products. So our definition: There is a monitoring process to confirm that state of control is maintained throughout that product lifecycle. The aim is to detect unplanned departures or unintended process variability from the process as designed. And I am sure that definition is not significantly different from how you use it in the USA.
How would we expect that to work in practice? In practice, companies spend an awful lot of time on what we call product quality reviews [PQRs] in Europe, and in America you call them annual product reviews [APRs]. We spend an awful lot of time preparing that document. And I have always thought, ‘do we actually get any benefit from doing it?’ So hopefully with the introduction of ongoing process verification, that could be used to confirm that the process is in a state of control.
There may also be some circumstances where you have a written PQR or you want to look at a specific issue. And under these circumstances you could also write a specific protocol or write a specific report to confirm some aspects of ongoing process verification.
Again, the frequency by which you perform it should be based on the lifecycle. For example, if it is a new product, you would expect it to be more frequent than an established product.
I should have said at the beginning when I presented this that we changed ‘continued process verification’ to ‘ongoing process verification,’ because we thought there was confusion between continuous and continued. So the terminology has changed. I apologize for not saying that earlier. In American terms, this is continued process verification.

wongscm

Thanks for sharing of Continuous  & Continued meaning.

dongqisheng

Thanks for sharing of Continuous  & Continued meaning.