CAJ | 학술논문

目的：验证所采用的灭菌注射用水分装、灭菌生产工艺符合2010年版《药品生产质量管理规范》附录1的规定,同时满足产品安全性、生产可靠性的要求。方法：以安瓿分装0.5ml/支的灭菌注射用水为研究对象,对影响灭菌注射用水质量的分装、灭菌生产工艺过程进行确认,并进行历史数据的统计分析。结论：通过验证,所有结果符合方案所述的要求,使产品最终达到成品检定标准。
목적：험증소채용적멸균주사용수분장、멸균생산공예부합2010년판《약품생산질량관리규범》부록1적규정,동시만족산품안전성、생산가고성적요구。방법：이안부분장0.5ml/지적멸균주사용수위연구대상,대영향멸균주사용수질량적분장、멸균생산공예과정진행학인,병진행역사수거적통계분석。결론：통과험증,소유결과부합방안소술적요구,사산품최종체도성품검정표준。
Objective： To determine whether the adopted filling and sterilization process follow the rules specified in Attachment 1, Chinese GMP（2010 Edition） and meet the requirements of product safety and production reliability. Methods：The ampoule that filled with 0.5ml of sterilized WFI was employed to serve as the subjects to confirm the filling and sterilization process that affect the quality of sterilized WFI. Meanwhile, the historical data were statistically analyzed. Results：All results met the requirements in Attachment through validation. Conclusion：All the products reach the testing standards.