APIC更新其清洁验证指南中的PDE概念

GMP News
02/11/2016

APIC updates 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 Cleaning Validation in Active Pharmaceutical Ingredients Plants", we already reported about the APIC "Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Now, a revision has brought the APIC guidance in line with EMA's guideline on "Shared Facilities".  

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 the guideline is now 57 pages long. The document frequently uses the term PDE beside the criterion ADE so far mentioned. Both terms ADE/PDE i.e. ADE or PDE can be found. Whereby, it is stated in the document that the guidance preferably refers to ADE in the calculations examples as it enables a better comparison to the examples listed in the ISPE document Risk MaPP. A new element in Chapter 4 is the calculation formula for PDE with explanation of the respective abbreviations. The glossary has been updated accordingly. Moreover, editorial changes 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 Cleaning Validation in Active Pharmaceutical Ingredients Plants" in its current version from September 2016 has now introduced the PDE concept consequently. The content changes are only marginal though, as the PDE concept supplements only 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 at ECA?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.  In addition a comparison of the May 2014 Version with the September 2016 Revision is 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。

来源;Julia

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