APIC更新其清洁验证指南中的PDE概念

julia朱玉姣

中英文版已上传，修改部分红色标识。基本内容此次修订没有啥改动……


GMP News
02/11/2016

APICupdates its Guidance on Cleaning Validation with regard to the PDE Concept

APIC更新其清洁验证指南中的PDE概念

In our news dated 11 June 2014 entitled "APIC publishes Guidance on CleaningValidation in Active Pharmaceutical Ingredients Plants", wealready reported about the APIC "Guidance on Aspects of CleaningValidation in Active Pharmaceutical Ingredients Plants". Now, a revisionhas brought the APIC guidance in line with EMA's guideline on "SharedFacilities".   

在我们2014年6月11日题为“APIC发布原料药车间清洁验证指南”的新闻中，我们已经报道了APIC的“原料药车间清洁验证指南”。现在，APIC对其进行了修订以保持与EMA关于共用设施的指南。

The original 55-page document is still divided into 13 chapters:

原来的55页文件现在仍分为13章：

• Foreword 前言
• Objective 目的
• Scope 范围
• Acceptance criteria 可接受标准
• Levels of Cleaning 清洁分级
• Control of Cleaning     Process 清洁工艺控制
• Bracketing and Worst     Case Rating 分组法和最差情形分级法
• Determination of the     Amount or Residue 残留数量的确定
• Cleaning Validation     Protocol 清洁验证方案
• Validation Questions 验证问题
• References     参考文献
• Glossary 术语
• Copyright and     Disclaimer 版权和免责声明
  

The main changes were made to Chapter 4 on Acceptance Criteria so that theguideline is now 57 pages long. The document frequently uses the term PDEbeside the criterion ADE so far mentioned. Both terms ADE/PDE i.e. ADE or PDEcan be found. Whereby, it is stated in the document that the guidancepreferably refers to ADE in the calculations examples as it enables a bettercomparison to the examples listed in the ISPE document Risk MaPP. A new elementin Chapter 4 is the calculation formula for PDE with explanation of the respectiveabbreviations. The glossary has been updated accordingly. Moreover, editorialchanges have been made to the document.

主要变化在第4章可接受标准，这样指南现在成为57页长了。除了ADE标准外，文件频繁使用术语PDE。术语ADE和PDE，即ADE或PDE都可以找到。在这里，文件中声明指南倾向于在计算例子中引用ADE，因为它更容易与ISPE文件风险MAPP中所举例子进行比较。第4章中新的内容是PDE的计算公式，以及各缩写的解释。术语进行了相应更新。另外，还对文件进行了编辑方面的修订。

Conclusion: The revision of the APIC "Guidance on Aspects of CleaningValidation in Active Pharmaceutical Ingredients Plants" in its currentversion from September 2016 has now introduced the PDE concept consequently.The content changes are only marginal though, as the PDE concept supplementsonly the previous ADE concept.

结论：APIC“原料药车间清洁验证指南”2016年9月的现行版本现在引入了PDE概念。其内容变化很有限，因为PDE概念只是对之前ADE概念的补充。

One of the authors of the APIC Cleaning Validation Guideline will speak atECA´s Cleaning Validation Course.

APIC清洁验证指南的作者之一将在ECA的清洁验证课程中演讲。

You can find the revised document on the APIC-Website.  Inaddition a comparison of the May 2014 Version with the September 2016 Revisionis available in the Members' Area on the ECA Website.

你可以在APIC官网上找到修订后的文件。另外，与2014年5月版本的比较可以在ECA官网的会员区里找到。

beiwei5du

刚看了一下2014与2016两个版本的。在2014版本中其实有提及到：
The draft EMA/CHMP/CVMP/SWP/169430/2012 makes reference to the Permitted DailyExposure (PDE). The PDE uses the no observed effect level (NOEL) instead of the noobserved adverse effect level (NOAEL) used in the ADE calculation. The PDE may also beused as alternative to the ADE to calculate the MACO.有说到PDE代替ADE进行计算的呢，只是在原文中没有提及到PDE的计算公式。2016版仅仅将Guideline on setting health based exposure limits for use6 in risk identification in the manufacture of different medicinal products in shared facilities中PDE的计算公式引入而已？？？

冷血无情

额，我就想问一个事儿，朱版啥时候出双语的

scslk0045

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334352444

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chenjiao501

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yangchb

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julia朱玉姣

beiwei5du 发表于 2016-11-2 22:20
刚看了一下2014与2016两个版本的。在2014版本中其实有提及到：
The draft EMA/CHMP/CVMP/SWP/169430/2012  ...

是的，把注释给删除了，增加了几句话而已 ，没有实质性修改

calyn

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大米

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l47816839

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小新1732ok

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kc1711422001

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zluo521

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谢谢楼主 已下载学习

yangyulongtj

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xmaysy

Julia, 谢谢！

safsaf

谢谢楼主分享

luislu

正好需要。感谢楼主分享