中英对照-APIC 原料药厂清洁验证指南：8.0残留量检测.docVIP

APIC 201405原料药厂清洁验证指南：8.0残留量检测（上）（中英文） 8.0 Determination of the Amount of Residue 残留量的检测 8.1 Introduction 介绍 This section provides a practical guidance for the determination of the amount of residue in cleaned equipment based on the requirements from regulatory authorities[1] and current guidelines on analytical validation.[2] Specific requirements for the validation of analytical and sampling methods for cleaning validation purposes are provided in this section, in addition to examples of sampling methods and the appropriate use of analytical methods. 本部分根据药监当局的要求和现行分析方法验证指南，提供了检测已清洁设备中残留物数量的实用指南。在本部分中给出了清洁验证中所用分析方法和取样方法的验证要求，以及取样方法和适当使用分析方法的例子。 The carryover acceptance limit (Mper) is a calculated figure that represents the specification limit for the equipment cleanliness (see Section 4.0, Acceptance Limits), however, the determination of the actual amount of residue (M) remaining in the equipment following cleaning must be achieved using appropriate methods i.e. for both the sampling method and the quantitation of the contaminant in the sample. 允许残留限度（Mper）是一个计算出的数值，代表设备清洁程度的质量标准限度（参见4.0部分，可接受限度），但是，对清洁后设备中残留物（M）实际数量的检测必须使用适当的方法来获得，即，针对取样方法和样品中污染物的定量。 Since the decision on the acceptable cleanliness of the equipment bears a potential risk to product quality, the method(s) used for the determination of M must be validated1 and the specificity, sensitivity and recovery of the method(s) should be determined as a minimum. 由于对设备可接受清洁度的决定会对产品质量有潜在风险，因此用于M检测的方法必须进行验证，必须至少验证方法的专属性、灵敏度和回收率。 8.2 Validation Requirements 验证要求 8.2.1 General 通则 The requirements for analytical method validation are defined in ICH Q2(R1), Validation of Analytical Procedures: Text and Methodology, November 2005. There are four types of analytical methods with principally different validation requirements; these are identification tests, tests for impurities (both quantitative and limit tests) and assay tests. The validation requirements for each method type are shown Table 1. 分析方法验证的要求在ICH Q2(R