PDA TR57（中文）生物技术产品的分析方法验证与转移.pdfVIP

Analytical Method Validation and Transfer for Biotechnology Products 生物技术产品的分析方法验证与转移 Technical Report No. 57 技术报告第57号 ISBN: 978-0-939459-41-4 © 2012 Parenteral Drug Association, Inc. All rights reserved. 1 Introduction 简介 1 1.1 Scope and Purpose 范围与目的 1 2 Glossary of Terms 术语5 2.1 List of Abbreviations 缩略词 15 3 General Assessment of Method Validation Readiness 方法验证准备的一般评估 16 3.1 General Risk Assessment Process 一般风险评估流程21 3.2 Setting AMV Protocol Acceptance Criteria 制定AMV方案验收标准25 3.2.1 Rationale 理论依据25 3.2.2 Consistent Risk Assessment to Set Acceptance Criteria 通过持续风险评估来制定验证 标准26 3.3 Example for AMV Protocol Acceptance Criteria AMV方案验收标准示例27 3.3.1 Setting and Justifying Acceptance Criteria for the AMV Protocol 制定和论证AMV方案 验收标准29 4 Analytical Method Validation 分析方法验证31 4.1 AMV Characteristics AMV项目34 4.1.1 Accuracy 准确度34 4.1.2 Repeatability Precision 重复精密度36 4.1.3 Intermediate Precision 中间精密度36 4.1.4 Reproducibility (Precision) 重现性 （精密度）38 4.1.5 Specificity 专属性38 4.1.6 Linearity 线性38 4.1.7 Range 范围39 4.1.8 Detection Limit (DL) 检测限40 4.1.9 Quantitation Limit (QL) 定量限40 4.1.10 Typical AMV Execution Matrix 典型AMV执行矩阵41 4.2 Additional AMV Characteristics to be Considered 其他应考虑的AMV项目42 4.2.1 Assay Bias and Analytical Response Factors 含量分析偏差和分析响应因子44 4.2.2 Stability of Samples, Standards, Controls, Reagents, and Material 样品、标准品、对