Content of current EU GMP Annex 16 is strongly influenced by EU Directives framework. Its proposed transposition by PIC/S is now focussing more on important technical elements of QP release decision(s
塌陷温度 (Collapse Temperature) 冻干时,干燥层温度上升到一定数值时,物料中的冰晶消失,原先为冰晶所占据的空间成为空穴,冻干层呈多孔蜂窝状海绵
2021-06-19美国 FDA 加速批准渤健(Biogen)阿尔茨海默病新药 Aduhelm 引发的争议已波及到该疾病领域之外,肌萎缩侧索硬化症(ALS)倡导者对 FDA 在 ALS 领域
Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984Garth Boehm (a), Lixin Yao (a), Liang Han (a,b), Qiang Zheng (a,c,*)a. Center for Pharmaceutical Information and En
识林邀请海问上海和北京办公室生命科学业务与医药健康领域的合伙人吴婷律师,在(2021年) 6 月 29 日(周二)上午 9:00-10:30 举行线上讲座 , 会议性质
IPEM将于6月24-27日举办关于生物制品和疫苗GMP法规解读和合规实践的教学课程。为期四天的课程重点关注疫苗和生物制品是如何按照国际标准的cGMP要求生
4.10 The data governance programme should include policies and procedures addressing data management. These should at least whereapplicable, include:data classification,confidentiality and privacy;
制冷系统是冻干机的重要组成部分,其主要作用是给冷阱和隔板(板层)降温和控温。而最常见的制冷系统是由压缩机及制冷剂为主体的机械制冷系统
>> The process simulation test should imitate as closely as possible the routine aseptic manufacturing process and include all the critical manufacturing steps...>> Annex 1 : Manufacture of Sterile Pr
Why is Steam Quality Testing considered so important by SRA inspectors? What should a company wishing to be compliant with WHO/PICs/EU/MHRA cGMP be doing and why?Ian Thrussell – GMP Consultant, Park
The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public he
2021 年 6 月 1 日上午 8:30-10:30(北京时间),识林将再次携手 IPEM 教育项目和美国霍金路伟(Hogan Lovells)律所举行线上讲座,介绍 FDA 细胞治疗产品的法
生产线之前的产品10批一清洁,已经做过验证及清洁效期的确认,现拟增加为11批一清洁(清洁方式、存放方式等都不变,只是批数增加)。问:是否还
我们需要把采血袋从普通传递窗表面擦拭消毒传递到B级区,需要做哪方面的验证,怎么做合适,传递窗有风淋和紫外
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