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.
关键词
无菌药品/疫苗/污染控制策略/有效性/检查
Key words
sterile medicines/vaccine/contamination control strategy/effectiveness/inspection
维普
万方数据