ECA目视检查最佳方法报告

麦田.守望

ECA's best practice paper on visual inspection

The best practice paper has been originally developed by the advisory board of the ECA Visual Inspection Group. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues. A regular update of the paper is intended to keep it up to date.

After the successful launch of the second version of ECA's best practice paper on visual inspection at the ECA conference "Particles in Parenterals 2016" in Barcelona, the third edition is now available for all members.

>> Download Good Practice Paper Version 3.0 of the Visual Inspection of Medicinal Products for Parenteral Use.

补充内容 (2017-11-23 12:46):
中文x.x版：https://www.ouryao.com/thread-320609-1-1.html

麦田.守望

Container/Closure Integrity Testing Position Paper

There seems to be an increasing uncertainty in the pharmaceutical industry regarding the integrity testing of sterile containers. Companies start to invest in 100% testing systems before defining the underlying concept adequately – leading to new questions. A 100% testing does not mean a 100% safety! That’s why the Board of the ECA Visual Inspection group worked on a position paper regarding container/closure integrity testing of sterile injectables.

The new paper is in line with the requirements of the EU Pharmacopeia and reflects current industry practices. It shows what a CCI control strategy could look like.

>> Download Container/Closure Integrity Testing Position Paper – Version 1.1.

globle002

thanks fo rsharing

麦田.守望

Presentations

Steven Langille >>> Presentation of ECA Particles 2014 24-25 September 2014 Bernd Renger >>> Regulatory Requirements, ECA Particles 2014 24-25 September 2014 Tobias Posset Pharma Congress 2014 >>> Implementation of an automated inspection system

麦田.守望

Q&As on Visual Inspection
08.09.2016

With the goal to better structure the existing Q&A document, to avoid questions to be asked several times, to make it easier to find already existing questions & answers – and, of course, to include your new questions, the Visual Inspection Group’s Board evaluated, restructured and discussed all answers to questions provided so far. Please find as a result Version 2.0 of the Q&A document.

The topics are structured in the following manner:

• Manual inspection
• Automated inspection
• Qualification / Validation
• Test sets
• Requalification
• AQL-Testing
• Defect categorisation
• Special products
• Regulatory Affairs
• Process-Control / SPC
  

volador

GOOD PRACTICES IN VISUAL INSPECTION
http://www.dviaviation.com/files/45146949.pdf

kc1711422001

Thanks for sharing

静水蓝心

我整中文的，谢谢分享

syhorchid

学习一下

LingWang

Best Practice Paper Visual Inspection Vs 3.0
是什么时间发布的呀？@roadman

麦田.守望

无菌药品包装的密封完整性评估
http://www.bncc.org.cn/news/n1516.html

jyc071000

感谢分享！

简1511

xiexiefenxiang

麦田.守望

Best Practice Paper

The best practice paper has been originally developed by the advisory board of the ECA Visual Inspection Group. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues. A regular update of the paper is intended to keep it up to date.

The third edition was reviewed - and is now replaced by version 3.1. Besides some editorial changes, this version now comprises a precision with regard to the minimum AQL level for batch release. Further, the requirement for "sum of defects" has been deleted.
>> Download Good Practice Paper Version 3.1 of the Visual Inspection of Medicinal Products for Parenteral Use.

麦田.守望

26.06.2017
Visual Inspection Boardfinishes work on Container-/Closure-Integrity Document
目视检查委员会已完成其容器/密闭器完整性文件

Members of the ECA Visual Inspection Board havefinished their work on a position paper regarding Container-/Closure-Integritytesting. The new document discusses leak testing of sterile containers andhas been released as the uncertainty in the pharmaceutical industry increases,how integrity testing has to be handled in the near future. There is already anumber of companies preparing for a 100 % integrity testing, which is already amust for ampoules. But the testing of 100% of a batch does not give a 100%security. It is much more important that the concept of testing is adequate.For example a 100% testing does not answer the question, what tight is, or howtight a container should be. Another question should also be answered, before atesting is done: What kind of leaks or cracks should be detected. And how doartificial leaks correlate with the risk of microbial contamination? As the100% testing method must be validated, it should also be clear how artificialwholes or cracks can be made in a reproducible way.
ECA目视检查委员会成员已完成其关于容器/密闭器完整性测试立场文件。新的文件讨论了无菌容器的泄漏测试，由于药业不确定性增加因此已经发布，其中还讨论了不久的未来要如何处理完整性测试。已有大量公司准备进行100%的完整性测试，对于安瓿瓶来说这本来也是必须的。而对一批产品进行100%测试并不能保证100%安全。充分测试更为重要。例如，100%测试并不能回答容器应该要多紧的问题。另一个要回答的问题是在测试之前，要检出什么样的泄漏和裂纹，人为泄漏与微生物污染风险之间的相互关系如何？由于100%测试方法必须进行验证，因此还需要清楚人工检查或裂纹要如何才能重复。


The new ECA paper complies with the requirements fromthe European Pharmacopeia and reflects current industry practice. Itwill be further developed to a guidance and it will also be harmonised it withthe US Pharmacopeia. Further, relevant changes possibly necessary due to thenew EU Annex 1, which is under revision at the moment, will also be addressed.The paper will be presented at the upcoming event of the ECA Visual InspectionGroup, 10-12 October 2017 in Vienna.
新的ECA文件汇总了欧洲药典的要求，反映了当前药业的做法。这份文件将会被制订成为指南，还会与美国药典融合。另外，目前仍在修订过程中的新EU附录1可能会引起的相关变更。文件将会在维也纳2017年10月10-12日ECA目视检查组的活动预报中呈现。


The new paper can be found in the download section of the ECA Visual Inspection Webpage.
新的文件可以在ECA目视检查网页上下载。

一步之遥

thanks for share。

小金库

感谢分享，努力学习

delin

感谢，比较少见的文件

曾祥敏

谢谢分享谢谢分享谢谢分享

chy1

感谢分享，学习中