classification concerning solubility, ADE concept, therapeutic dose (1-3 oder 1-5). A table summarises the single data and identifies worst case products for the cleaning validation. Explicit reference is again made to change control which might make necessary a new worst case calculation.
根据其风险，对单个标准进行分类。在本指南中，提议按类别（清洁难易程度），以及按溶解度、ADE概念、治疗剂量（1-3 细分1-5）进行分类。文中给出了一张表，概括了个数据以及对清洁验证中最差情况产品的识别。这里再次明确批出要对可能需要计算新的最差情况的变更进行控制。
Determination of the Amount of Residue (chapter 8) 残留量的检测（第8章） At the beginning of chapter 8 a practical guidance is provided concerning the validation of analytical methods in the course of a cleaning validation; regulatory requirements (for example FDA) and guidelines are indicated (such as ICH Q2 R1). The second part addresses sampling methods (swab/rinse). A combination of the two methods is described as being generally the most desirable. Interestingly, the subchapter swab sampling mentions the analysis of the first production batch of the following product for impurities as \critical as concerns this procedure. For swab sampling as well as for rinse or solvent sampling equations are given.
在第8章开头就给出了关于清洁验证中分析方法的验证实用指南，指出了法规要求（例如FDA）和指南（例如ICH Q2R1）。第二部分写的是取样方法（擦拭取样/淋洗取样），以及两方法并用的方式。通常两法并用是实际所需要的。有意思的是，关于擦拭取样的章节中提到对下一产品第一个生产批次的杂质分析“可能”是一种选择。在FDA的清洁验证指南中，FDA对此相当关注。在文给出了擦拭取样、淋洗取样及溶剂取样的计算公式。
There is also mentioned a third method which is rather unknown - the so-called \or \These elements are placed on appropriate sampling points in the equipment and remain there during the manufacture of the previous product and during cleaning. After cleaning, the contamination on the coins is analysed and the overall contamination is calculated.
文中还提到第3种较少为人知的方法，称为“印章”或“硬币”法。该方法是将一个“硬币”贴在设备取样点，进行上一产品的生产和清洁，在清洁后，对“硬币”上的清洁物进行分析，计算整体污染水平。
Cleaning Validation Protocol (chapter 9) 清洁验证方案（第9章）
In chapter 9 you can find a cleaning validation protocol which is six pages long and divided into 9 chapters:
在第9章中，你会看到一份6页的清洁验证方案，分为9个部分： Background 背景 Purpose 目的 Scope 范围
Responsibility 职责 Sampling procedure 取样程序 Testing procedure 检测方法 Acceptance criteria 可接受标准 Deviations 偏差 Revalidation 再验证
In Chapter 10 \Questions\frequently asked questions are answered in the style of a Q&A paper. In this document \answered with references to the single chapters/subchapters in the document. 在第10章“验证问题”中，以问答方式对常见问题进行了回答。在本文件中，“A”是建议“ADVICE”的缩写。问题回答中参考了文件中相关章节。
The document is completed with the chapters 11 (References), 12 (Glossary) and 13 (Copyright and Disclaimer).
文件结尾是第11章（参考文献），第12章（术语）和第13章（版权和声明）。 Conclusion: 结论
In spite of the many pages the document can be read very well. The many practical examples (such as calculations, cleaning validation protocol,...) may be helpful. The document addresses the ADE concept very intensively. This is a question which confuses industry at the moment. But the document also addresses acceptance criteria
already known (dose criterion, amount criterion). It is striking that the document still adheres to the three batches concept. Although the document addresses active pharmaceutical ingredients plants it will surely find readers among manufacturers of medicinal products.
除了一些页面之外，整个文件还是非常易读的。许多实用性例子（例如，计算、清洁验证方案??）很有帮助。文件对目前困扰企业的ADE的概念进行了非常深入的阐述。但是，文件仍在说明大家已知道的可接受标准（剂型标准、数量标准）。令人注目的是该文件还是坚持3批的概念。尽管该文件已说了是针对原料药工厂，但无疑也会有一些制剂生产商参考它。