风险管理是确保无菌药品产品质量的关键因素之一。对无菌药品生产、分析检测等过程中的存在的风险因素进行识别和分析，进行风险等级的评估是进行无菌药品质量风险管理的前提条件。总结了无菌药品生产过程的质量风险因素、无菌药品生产质量风险评估和无菌药品生产的质量风险控制，以期无菌药品生产企业能够显著提升质量风险管理能力，进而创建一个高效、安全且稳定的无菌药品生产环境，确保最终产品的质量达到既定标准和规范。

Risk management is one of the key factors to ensure sterile drug product quality. Identifying and analyzing risk factors in the production, analysis, and testing process of sterile drugs, and conducting risk level assessments are prerequisites for quality risk management of sterile drugs. This article summarizes the quality risk factors in the production process of sterile drugs, the quality risk assessment of sterile drug production, and the quality risk control of sterile drug production, with the aim of significantly improving the quality risk management ability of sterile drug production enterprises, creating an efficient, safe, and stable sterile drug production environment, and ensuring that the final product quality meets established standards and specifications.

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