附件3:生物技术原料药生产中的案例研究的目标是提供特征操作的详细示例和案例研究，以证明实施QRM在生物技术原料药生产过程中有效管理风险的价值。本技术报告的每一部分首先概述生物制药制造过程的一个阶段以及与该阶段相关的典型风险，然后是一个案例研究，展示如何在该生产阶段应用QRM工具来控制、缓解和/或消除风险。本报告还包括QRM在可能影响生物制药制造的其他因素中的应用部分，如原料药的主要接触面、工艺流中的可提取物/浸出物以及环境控制。

The goal of Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances is to provide detailed examples of characteristic operations and case studies that demonstrate the value of implementing QRM to effectively manage risks during manufacturing of biotechnological bulk drug substances. Each section of this technical report begins with an overview of a stage of the biopharmaceutical manufacturing process and the typical risks associated with that stage, followed by a case study demonstrating how to apply a QRM tool to control, mitigate, and/or eliminate risks during that stage of production. This report also includes a section on the application of QRM to additional factors that can affect biopharmaceutical manufacturing, such as primary contact surface for drug substance, extractables/leachables in the process stream, and environmental controls.