先承认这是标题党... 欧盟 GMP（2022）附件 1 明确了专门针对 WFI 储罐的排气过滤器进行完整性测试的要求：“如果 WFI 储罐配备疏水性抑菌排气过

Given current FDA policies, what impact will there be on IND submissions for Chinese enterprises' gene therapy products, and how can they prepare in advance?

What situations trigger FDA surprise inspections? Will Field Alert Report (FAR) trigger them? Could you provide some examples?

What is the FDA's goal for overseas regulation? What direction does it guide pharmaceutical companies towards? Is it merely compliance, or are there other orientations?

What AI tools can help enterprises ensure internal compliance, accelerate real-time monitoring of submission data, and expedite the review of submission materials?

What are the innovations in FDA's review?

中国药企目前已经感受到了哪些方面的变化：审评尺度，缺陷程度，还是检查力度？受到了哪些影响？有哪些应对措施？这些变化是否是可逆的？What changes have Chinese pharmaceutical companies already felt: review standards, deficiency severity, or inspection

What are the FDA's regulatory trends for Chinese clinical study data (used for innovative drug submissions to FDA)?

What impact do recent FDA personnel and policy changes in the cell and gene therapy field have on Chinese enterprises conducting clinical studies in the U.S. in this area?

What types and conditions of enterprises might be subject to surprise inspections? What is the workflow for implementing inspections? Compared to previous inspections, what are the differences besides

Will changes in FDA personnel affect the review progress and standards of the Center for Devices and Radiological Health (CDRH)?

Which tracks in the Chinese pharmaceutical industry are mainly affected by recent FDA trends? Which type of pharmaceutical companies are most impacted?

项目已完成工艺验证，蛋白质含量分析方法已完整验证，但该方法之前没有增加系统适用性样品，现在需要增加系统适用性控制，请问需要做哪些工作

请教一下各位老师，产品的处方组成中，注射用水是当做溶剂体现，按照药典4部注射用水进行检验，但是实际操作是注射用水灭菌后使用，灭菌后没有

中国药典正文项下残留溶剂多余注册标准，在工艺中并未使用到那些溶剂，按照注册标准执行还是药典标准

FDA对只测试淋洗波是否足以支持清洁验证中的残留物测定?的问答案例分享

请教一下各位老师：生物制品的冻干制剂，半成品配制能浓缩冻干，便于冻干吗？就是比如我成品有效成分是100/ml，单人剂量为1ml，我半成品配制为200/m

房间清洁效期24h也同样，第23小时全部投入生产使用，又按照工艺规定灌装12h，此房间实际已过24h效期。以上效期计算方式均为实际运行情况，请问此种

根据《临床试验期间生物制品药学研究和变更技术指导原则（试行）》，水针改粉针属于可能增加安全性风险的生物制品药学变更；而《药物临床试验