清洁验证之分析方法-下(中英文版)（PDA TR 49内容节选7）
6.5 Analytical Method Validation 
6.5 分析方法验证 
This section focuses on analytical method validation for “chemical” residues. 
这部分关注化学残留的分析方法验证 
Typically, endotoxin methods are compendia methods and do not require formal validation but require a confirmation for their application of use or suitability. 
内毒素方法是药典方法，不需要正式的验证，但需要使用或者适用性确认。 
Microbiological methods that are approved microbiology laboratory methods do not require additional method validation. 
被微生物学实验室方法批准的微生物方法不需要额外的方法验证。 
6.5.1 General Principles 
6.5.1 基本原则 
Since one key part of cleaning validation is setting residue limits and then measuring (using an analytical method) the actual residues left on surfaces after cleaning, it is critical that the analytical method be appropriately validated. 
validation verification
因为清洁验证主要的一部分是设定残留限度，然后测量(使用分析方法)清洁后表面的实际残留。分析方法被 适当的验证是非常关键的。 
Method validation is typically accomplished using the criteria in ICH Q2(R1), Validation of Analytical Procedures: Text and Methodology.
(16) 方法验证是典型地完成，使用 ICHQ2(R1)分析方法验证程序：内容和方法学的标准。
However, the types of assays listed in ICH Q2 do not explicitly cover cleaning validation methods.
不管怎样，ICH Q2 上所列的内容类型，没有明确涵盖清洁验证方法。 
Some companies will essentially validate analytical methods much like an “assay” in ICH Q2, establishing accuracy, precision specificity, linearity and range, with the added determination of LOD/LOQ. 
一些公司将验证分析方法，如同 ICH Q2 的内容一样，建立精确度，精密度，专属性，线性和范围， 另外还有 LOD/LOQ 的测定。
LOD/LOQ must be below the acceptance limit for the sample and ideally is significantly below the acceptance limit so that the robustness of the cleaning process can be established.LOD/LOQ
必须低于样品接受标准限度，完美低于可接受标准限度以至于清洁程序的耐用性被建立。
In addition to the ICH Q2 parameters, sample stability as a function of storage conditions (time, temperature, vial, etc.) may be evaluated if there is a significant interval between sampling and analysis. 
除 ICH Q2 的参数之外， 样品稳定性作为存储条件 （时间， 温度， 瓶子等） 的一个功能因素要被评估， 如果取样和分析之间有一个重要间隔。
In cases where a nonspecific method (such as TOC) is utilized, it is not necessary to compensate for the lack of specificity by “other supporting analytical procedures” (as suggested in ICH Q2). 
为防止一个非特定方法（如 TOC）被应用，补偿缺少专属性的“其他支持分析程序”是非常有必要的。 
The reason for this is that for cleaning validation purposes, the limit value is not a target (as it is for a potency assay); rather the limit is a value not to be exceeded. 
这样做的原因是满足清洁验证的目的，限度值不是一个对象或者说限度是一个不被超越的值。
As long as other organic substances contribute positively to the TOC value, and as long as all measured carbon is attributed to the target residue, such complementary methods sugg
ested by ICH Q2 are not required.
由于其他有机物对 TOC 值影响很大， 和所有被测量的碳影响目标残留， 这个 ICH Q2 推荐的互补的方法 是不需要的。
Furthermore, it is not required to correlate TOC results with a specific analytical method, except to the extent that accuracy in method validation is established using a known standard that establishes the concentration or activity by a specific analytical method. 
此外， 不需要关联 TOC 结果和特定分析方法， 除非在分析方法验证中使用一个已知标准扩展精确度，这个标准通过特定分析方法建立了浓度或者活力。 
While Detection Limit and Quantitation Limit are not part of the “Assay” requirement in ICH Q2, it is critical that these values be at or below the preestablished limit for the residue (otherwise itwould not be possible to claim that residues were below the predetermined limit values). 
检测限和定量限不是 ICH Q2 中含量测定部分的要求， 这些值等于或者低于残留的预设限度
是非常关键的 （否则将不能说残留低于预定检测限度值。）However, it is not necessary to drive detection or quantitation limits as low as possible; having detection or quantitation limits around 10% of the residue limit in the analytical sample is ideal (but not always possible) to establish the robustness of the cleaning process. 
不管怎样，使检测和定量限尽量低是非常必要的；为建立清洁程序的耐用性，使检测和定量限在分析样品 中残留限度 10%的范围内是理想的（不是永远可行） 。Assay capability should take into account both the target/limit and the process capability and provide relevant measurements for both. 
含量能力需同时考虑目标/限度和工艺能力，并提供这两个方面的相关测量 When performing carryover calculations (as is typically done for the formulation/fill side of biotechnology manufacturing) it should be ensured that the analytical methods that will be used for cleaning validationare sensitive enough to meet the acceptance criteria. 
当执行残留计算（通常作为处方/生物制品生产灌装面）时，应该保证被用于清洁验证的分析方法足够灵敏 以至于满足可接受标准。
To provide reliable results for carryover calculations, the results should be equal to or above the LOQ. 
为残留计算提供可信任的结果，这个结果应等于或高于 LOQ 
Results between the LOQ and the LOD typically show a higher-than-acceptable variation of the resultsobtained and are typically reported as less than LOQ. 

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