APIC更新清洁验证PDE概念

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

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对齐。

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Worst Case Rating 残留数量的确定

Bracketing and

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 \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。