第54号技术报告的第一个附件:药品和生物技术生产运营质量风险管理的实施提供了如何将质量风险管理（QRM）应用于药品生产，特别是包装和标签运营的具体案例研究。本报告旨在与ICH Q9保持一致，是一系列类似文件中的一份，这些文件提供了如何在整个产品供应链中应用风险管理工具的其他示例。第54-2号技术报告由代表默克、安进和基因泰克等公司的全志愿专家团队起草。

The first Annex to Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides specific case studies on how to apply quality risk management (QRM) to pharmaceutical manufacturing, specifically packaging and labeling operations. This report is intended to align with ICH Q9 and is one in a series of similar documents that provide additional examples of how to apply risk management tools across the product supply chain. Technical Report No. 54-2 was drafted by an all-volunteer team of experts representing companies like Merck, Amgen and Genentech.