APIC更新清洁验证PDE概念.docxVIP

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 EMAs 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对齐。 The original 55document 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 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