Contamination Control Strategy and Inspection Points of Vaccine Manufacturing
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.
sterile medicinesvaccinecontamination control strategyeffectivenessinspection
万方数据
维普
