本技术报告为生物技术产品分析方法生命周期的开发和鉴定部分提供了基于风险的实用指南。方法开发从定义分析方法的要求开始，并导致但不一定以鉴定结束，鉴定是对方法性能的书面评估。本报告还包括分析方法开发和分析方法鉴定研究指南，如基于风险的策略和优先级、分析目标概况和设计概念质量、目标性能标准和现代质量期望。

This Technical Report provides practical, risk-based guidance for the development and qualification portions of the analytical method lifecycle for biotechnology products. Method development begins with defining the requirements for the analytical method and leads to, but does not necessarily finish with, its qualification, which is a documented assessment of method performance. Guidance for analytical method development and analytical method qualification studies, such as risk-based strategies and priorities, analytical target profile and quality-by-design concepts, target performance criteria, and modern quality expectations is also included in this report.