Ermer J
Aventis Pharma AG, Global Analytical Development, QOTSS, Poseidonhaus, D-65926 Frankfurt am Main, Frankfurt, Germany.
J Pharm Biomed Anal. 2001 Mar;24(5-6):755-67. doi: 10.1016/s0731-7085(00)00530-6.
The ICH guidelines achieved a great deal in harmonising the definitions of the required validation characteristics and their basic requirements. However, they provide only a basis for a general discussion of the validation parameters, their calculation and interpretation. It is the responsibility of the analyst to identify parameters which are relevant to the performance of the given analytical procedure as well as to design proper validation protocols including acceptance criteria and to perform an appropriate evaluation. In order to fulfil this responsibility properly, the background of the validation parameters and their consequences must be understood. In this part, the general concept of an integrated validation is discussed. The interdependencies to other ICH guidelines and topics during drug development (e.g. impurities and degradants, stability and specification design) must be taken into account to define the required acceptance criteria. Evaluation of the results in order to prove the suitability of the analytical procedure must be based on the specification limits. Important parameters and aspects are discussed for the individual validation characteristics. In the following parts, these parameters will be discussed in detail. Examples will be given for their interpretation in order to facilitate the selection of parameters which are relevant to the performance and suitability of the given analytical procedure.
国际人用药品注册技术协调会（ICH）指南在统一所需验证特性的定义及其基本要求方面取得了很大成就。然而，它们仅为验证参数、其计算和解释的一般性讨论提供了基础。分析人员有责任确定与给定分析程序性能相关的参数，设计包括验收标准在内的适当验证方案，并进行适当的评估。为了正确履行这一职责，必须了解验证参数的背景及其影响。在本部分中，将讨论综合验证的一般概念。在药物开发过程中，必须考虑与其他ICH指南和主题（如杂质和降解产物、稳定性和规格设计）的相互依赖性，以确定所需的验收标准。为证明分析程序的适用性而对结果进行的评估必须基于规格限度。将针对各个验证特性讨论重要参数和方面。在接下来的部分中，将详细讨论这些参数。将给出其解释示例，以便于选择与给定分析程序的性能和适用性相关的参数。
