最终灭菌的产品，改变灭菌装载方式，怎么进行变更分类，变更内容为产品单盘排列方式 每排减少1瓶， 增加1列。

用于混悬剂的全自动灯检机设备性能确认的疑问：1. 混悬剂本身包装是BFS一次成型，透过性不强，溶液本身就有一定粒径的颗粒物，那么灯检的标准如

请教一个问题，BE备案后换BE批次，需要撤回BE备案吗？备案表撤回情形没提这一条，个人理解应该是需要的。下图可见，备案资料是需要明确BE批次信息

《药品上市后变更管理办法》中第十条提及“已在境内上市的境外生产药品转移至境内生产的，应当由境内申请人按照药品上市注册申请的要求和程序

根据2021年发布的临床变更指导原则，此变更属于重大变更A类，需要提交临床相关文件，但若国内已批准，是否采用文献替代即可？

Good manufacturing practices: water for pharmaceutical use 药品生产质量管理规范: 制药用水

背景: 产品具有引湿性，按照ICH指南进行稳定性考察现象：按照ICH稳定性考察指南，进行产品留样稳定性考察，每包的留样量为不超过检验量的2倍，结

新购置了生产设备，内包材质量标准中规格尺寸发生变化，同时新增内包材生产商。新旧两种生产设备因模具不同，导致包材有两个规格尺寸，如何解

The COVID-19 pandemic resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities suspended due to

Torrey Cope looks at the recent FDA emphasis on the challenges of a China-only trial strategy. He explores the FDA concern that a China-only clinical trial will be unable to prove that a drug is suita

Due to COVID-19, many pharmaceutical manufacturing sites have not experienced a regulatory inspection in several years. Raj Pai discusses how to ensure that Good Manufacturing Practices are in place.D

Following our recent post highlighting potential compliance risks at emerging cellular and gene therapy companies, Stephen Abreu and Chris Fanelli provide some questions and topics to explore when c