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APIC updates its Guidance on Cleaning Validation with regard to the PDE Concept
APIC更新其清潔驗(yàn)證指南中的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".  
在我們2014年6月11日題為“APIC發(fā)布原料藥車間清潔驗(yàn)證指南”的新聞中，我們已經(jīng)報道了APIC的“原料藥車間清潔驗(yàn)證指南”。現(xiàn)在，APIC對其進(jìn)行了修訂以保持與EMA關(guān)于共用設(shè)施的指南。

The original 55-page document is still divided into 13 chapters:
原來的55頁文件現(xiàn)在仍分為13章：
Foreword 前言
Objective 目的
Scope 范圍
Acceptance criteria 可接受標(biāo)準(zhǔn)
Levels of Cleaning 清潔分級
Control of Cleaning Process 清潔工藝控制
Bracketing and Worst Case Rating 分組法和最差情形分級法
Determination of the Amount or Residue 殘留數(shù)量的確定
Cleaning Validation Protocol 清潔驗(yàn)證方案
Validation Questions 驗(yàn)證問題
References 參考文獻(xiàn)
Glossary 術(shù)語
Copyright and Disclaimer 版權(quán)和免責(zé)聲明

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.
主要變化在第4章可接受標(biāo)準(zhǔn)，這樣指南現(xiàn)在成為57頁長了。除了ADE標(biāo)準(zhǔn)外，文件頻繁使用術(shù)語PDE。術(shù)語ADE和PDE，即ADE或PDE都可以找到。在這里，文件中聲明指南傾向于在計算例子中引用ADE，因?yàn)樗菀着cISPE文件風(fēng)險MAPP中所舉例子進(jìn)行比較。第4章中新的內(nèi)容是PDE的計算公式，以及各縮寫的解釋。術(shù)語進(jìn)行了相應(yīng)更新。另外，還對文件進(jìn)行了編輯方面的修訂。

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.
結(jié)論：APIC“原料藥車間清潔驗(yàn)證指南”2016年9月的現(xiàn)行版本現(xiàn)在引入了PDE概念。其內(nèi)容變化很有限，因?yàn)镻DE概念只是對之前ADE概念的補(bǔ)充。

One of the authors of the APIC Cleaning Validation Guideline will speak at ECA?s Cleaning Validation Course.
APIC清潔驗(yàn)證指南的作者之一將在ECA的清潔驗(yàn)證課程中演講。

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官網(wǎng)上找到修訂后的文件。另外，與2014年5月版本的比較可以在ECA官網(wǎng)的會員區(qū)里找到。