PCMOSM PDA第54号技术报告:制药和生物技术生产运营质量风险管理的实施为在整个产品生命周期中应用和实施质量风险管理（QRM）原则提供了详细指导。为了与ICH Q9保持一致，并提供有助于读者实施QRM的信息，本报告强调了QRM在商业制造过程中的应用，并将QRM整合到药品质量体系中。

PCMOSM PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides detailed guidance for the application and implementation of quality risk management (QRM) principles throughout the product lifecycle. Intended to align with ICH Q9 and present information that can be helpful to the reader on how to implement QRM, the report emphasizes QRM application during commercial manufacturing and integrating QRM into the pharmaceutical quality system.