EDQAOMCL分析方法验证指南

VALIDATION OF ANALYTICAL PROCEDURESGUIDELINE FOR OMCLsOMCL分析方法验证指南INTRODUCTION 概述The two ICH Guidelines on “Validation of Analytical Procedures: “Definitio n/ Terminology and Methodology” (Q2A and Q2B) constitute a discussion o f the validation characteristics that should be considered during the validatio n of an analytical procedure (the guideline has also been adopted for veteri nary products during VICH discussion). They are primarily addressed to pha rmaceutical industry indicating which validation data need to be provided in an application file. These data should demonstrate that the proposed testing and acceptance criteria are sufficiently under control to guarantee reproduci ble quality of the products at release and adequate control during shelf-life (stability).两个关于分析方法验证的ICH指南“分析方法的验证”和“定义/术语和方法学”（Q2A和Q2B）包括了一个分析方法验证中应该考虑的验证特性的讨论（该指南在VICH讨论中也被应用于兽药产品），它们告诉制药企业在提交申请文件时，需要提供哪些验证数据。

这些数据应证明所提交的检验项目、方法、可接受标准是受控的，足以保证产品放行质量重现性及其生命周期（稳定性）内质量充分受控。

As the circumstances under which an OMCL works are different from those of a pharmaceutical company –in most cases no routine analysis, but ofte n responses to be made in a short period of time -, the extent of analytical validation requested before performing an analysis needs to be reconsidered. On the other hand it has in all cases to be guaranteed that the result sub mitted is reliable. It should also be emphasised here, that adequate reference materials are an important factor in both the performance of the validation studies and the analysis it-self. The use of widely accepted reference prepa rations can in certain circumstances avoid the consideration of some validation characteristics, mainly in the field of biological products: this has then t o be justified on a case by case basis.由于OMCL的工作情况与制药公司并不一样---在大多情况下，并没有常规检验，但经常需要在很短时间内做出反应，在进行分析前所要求的方法验证的程度需要再进行考虑。

另一方面，在所有情况下都需要保证所呈交的结果是可靠的。

在此还需要强调的是，在验证研究和分析检测中对照物质均是重要的因素，采用被广泛认可的对照品在某些特定情况下可以避免考虑某些验证特征，这主要表现在生产产品方面，这些需要个案单独判断。

The scope of this document –specifically addressed to OMCLs - is to give guidance on the extent of validation needed, depending on various circums tances i.e. objective of the analysis (e.g. screening for non compliance), am ount of validation data already available (e.g. in case of a method transfer), experience or historical data already available in the individual OMCL (e.g. recovery from a complex matrix; routine use of a standard titration even if different substances are titrated), etc. This document is equally applicable t o products of synthetic and of biological origin. It does not address commo n laboratory practice: for instance specific use of the equipment, calibration etc.本文件的范围—尤其对于OMCL来说—是提供验证所需进行的深度的指南，它取决于不同的环境，也就是分析的目的（例如，剔除不符合者），已有验证数据的数量（例如对一个方法进行转移的情况），在单个OMCL实验室已有的历史数据和经验（例如，一个复杂矩阵的回收率，即使是对不同物质同样适用的常规标准滴定法）等等。

本文件同等适用于合成产品和生化产品。

本文件未对一般化验室规范提出要求，例如仪器的特定使用、校正等。

This document is a note for guidance, which provides detailed recommendat ions of the extent of the validation exercise dependent on the category of t he analytical procedure; it should be noted that other approaches are always possible. In all cases a short description and/or justification of the approac h chosen, including the methods, should be described in the internal docum entation of the analysis. Validation data of validated methods (compendial,marketing authorisation dossier) should be available. Modifications from the original validated method should be justified. The same definitions as in the ICH document apply.本文件是对指南的一个注释，其中详细说明了验证的深度取决于分析方法的类别，需要注意的是总会有一些其它方法来实现相同目的。

不管怎样，对所选择方法的论述，包括方法本身，应在内部分析文件中做一个简短的描述。

已验证方法（药典、上市文件）的验证数据应该保存可查，对原始的经过验证的方法进行修订需要进行论证。

ICH文件中的定义在此适用。

CATEGORIES OF ANALYSIS 分析的类别This chapter defines the different analytical situations (categories) which mig ht occur in an OMCL and the corresponding validation characteristics which should be considered. (As a reminder the table in the annex describes in general the validation characteristics to be considered, depending on the diff erent types of analytical procedures).本章定义了可能发生在一个OMCL里的不同分析情况（类别），以及需要考虑的相关的验证特性。

（附件表中描述了根据不同分析程序类别需要考虑的验证特性供参考）Formal validation studies , according to the ICH requirements, has to be pe rformed for a new developed method or when for an existing method the v alidation data have to be completed.正式验证研究：根据ICH指南，对于新建方法，或已有方法需要提交完整数据时必须实施Method transfer check (verification of suitability ) has to be done to show that under actual conditions of use in the individual laboratories the metho d is adequate (fit for use). This might imply for instance the carrying out of the system suitability tests (e.g. resolution in a chromatographic method), the control of the reporting threshold, the control of the completeness of a reaction step (e.g. extraction, hydrolysis reaction) before the actual determi nation can be performed, the verification of the precision of the method etc. So for instance the system suitability tests described in a fully validated li quid chromatography method will in all cases have to be performed, as the se tests are part of the analytical procedure. This is particular true for the category ‘Transfer of a method’.方法转移检查（适用性验证）：方法转移检查必须要进行，以表明该方法在指定的实验室内在实际使用情况下，方法可以满足使用的要求。