基于质量风险管理的生物制药工艺验证策略

A risk-based approach for biopharmaceutical process validation

目的 :根据美国、欧盟等药品监管部门以及ICH提出的基于生命周期的工艺验证方法,将风险管理运用到整个工艺验证的生命周期。方法 :本文采用风险管理的方法对工艺设计阶段、工艺确认阶段以及持续工艺验证阶段进行了探讨。结果 :证明基于风险的工艺开发和验证合并将产生更可靠、更持续可行的工艺,从而确保持续稳定地生产出符合预定用途和注册要求的药品。结论 :通过符合更好的工艺实践,生物制药将进一步推动制药行业的发展。

Objective： Risk management can be applied throughout the process validation cycle according to a risk- based approach for the life cycle of process validation established by drug regulatory departments in the United States, the European Union and ICH. Methods： The methods for risk management used in process design, process qualification, as well as continuous process verification are discussed in this article. Results： The combination of the process development and validation based on the risk will be confirmed to produce more reliable, sustainable and feasible process to ensure stable production of drugs in line with the intended use and drug registration requirements. Conclusion： Biological pharmaceutical will further promote the development of the pharmaceutical industry by better process practice.