灭菌、无菌工艺验证.pdf

灭菌/无菌工艺验证指导原则（第二稿)

目录

1概述...............................................................................................................................................1
2制剂湿热灭菌工艺........................................................................................................................3
2.1湿热灭菌工艺的研究.........................................................................................................3
2.1。1湿热灭菌工艺的确定依据..................................................................................3
2。1。2过度杀灭法的工艺研究....................................................................................4
2。1.3残存概率法的工艺研究.......................................................................................5
2.2湿热灭菌工艺的验证.........................................................................................................6
2。2.1物理确认...............................................................................................................6
2。2.2生物学确认..........................................................................................................8
3制剂无菌生产工艺......................................................................................................................10
3.1无菌生产工艺的研究.......................................................................................................10
3.1.1无菌分装生产工艺的研究....................................................................................10
3。1。2过滤除菌生产工艺的研究.............................................................................11
3。2无菌生产工艺的验证...................................................................................................11
3.2。1培养基模拟灌装试验.........................................................................................12
3.2.2除菌过滤系统的验证...........................................................................................14
4原料药无菌生产工艺..................................................................................................................17
4.1无菌原料药生产