在高度监管的制药行业，重要的是在整个供应链和产品生命周期中正式识别、减少、控制和有效沟通重大风险。行业领导者和监管机构都明白，药品的生产和使用存在一定程度的固有风险，但他们的共同目标是保护患者。正式的风险管理工具可用于有效记录和传达这种控制。ICH质量指南Q9:质量风险管理介绍了风险管理的一般原则和各种风险管理工具的示例。 然而，Q9并没有提供如何在现实制药环境中使用这些工具的细节。本文件旨在通过行业案例研究弥合这一差距，以说明各种风险管理工具是如何应用的。虽然没有一种方法可以应用质量风险管理，但PDA技术报告第54-3号，药品和生物技术生产运营质量风险管理的实施附件2:药品生产案例研究提供了如何将质量风险管理应用于药品生产的具体案例研究。 这些案例研究由PDA第54号技术报告补充附件《药品和生物技术制造作业质量风险管理的实施》中的技术报告小组选择，以说明质量风险管理工具的适应性，帮助解决各种问题，实施纠正措施，并使过程处于受控状态。

In the highly regulated pharmaceutical industry, it is important that significant risks be formally identified, reduced, controlled, and effectively communicated throughout the supply chain and the product lifecycle. Both industry leaders and regulatory authorities understand that some degree of risk is inherent in the manufacturing and use of drug products, but they share the common goal of protecting the patient. Formal risk-management tools can be used to effectively document and communicate this control. ICH Quality Guideline Q9: Quality Risk Management presents general principles of risk management and examples of various risk management tools. However, Q9 does not provide details on how to use these tools in real-world pharmaceutical situations. This document is provided to bridge this gap using case studies from industry to illustrate how various risk management tools are applied. While there is no one way to apply quality risk management, PDA Technical Report No. 54-3, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products provides specific case study examples of how to apply quality risk management to the manufacturing of pharmaceutical drug products. These case studies were chosen by the technical report team, of this supplemental annex to PDA Technical Report No. 54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, to illustrate the adaptability of quality risk management tools to help solve various problems, implement corrective actions, and keep processes in a state of control.