疫苗生产污染控制策略及检查要点分析

Contamination Control Strategy and Inspection Points of Vaccine Manufacturing

药品为预防、控制和治疗疾病提供了强大的保障,在全球公共卫生体系中扮演着至关重要的角色,疫苗作为特殊的药品,其生产工艺更为复杂,是近年来药品监管部门关注的重点。自新版欧盟GMP附录一提出污染控制策略(CCS)以来,CCS已受到药品生产企业和药品检查人员的广泛关注。本研究以疫苗生产工艺过程为主线,结合近几年疫苗检查发现的CCS相关缺陷,分别从人员污染控制、设备与组件污染控制、物料污染控制、设施与环境污染控制、清洁验证等方面分析疫苗污染控制的关注要点。

Pharmaceuticals provide a strong guarantee for the prevention,control and treatment of diseases,and play a key role in the global public health system.The latest EU GMP Annex 1 Manufacture of Sterile Medicinal Products proposes a concept of contamination control strategy(CCS),it has received widespread attention from medical manufacturers and inspectors.Based on the vaccine manufacturing process and the CCS-related inspection defects in recent years,this study analyzes the key points of vaccine Contamination control strategy from the aspects of personnel,equipment,component,material,facility,environmental and cleaning validation.