【各省级药品监管部门应当通过事前沟通等方式，指导申请人在完成支持药品上市注册的药学、药理毒理学和药物临床试验等研究，确定质量标准，完

在做库房温湿度分布验证时，门口的监测点是放在门内还是门外？

在菌种传代稳定性研究中，指导原则要求开展模拟传代稳定性研究及实际生产工艺传代稳定性研究，请问模拟传代稳定性研究是什么概念及研究的意义

有没有法规原文或者药典原文规定，所有产品的铝塑板或者药瓶包装的，在包装过程中要取样检测气密性？

限制进入屏障系统（Restricted Access Barrier System, RABS）是一种广泛应用于无菌药品生产的关键技术，其通过刚性屏障、手套端口和单向气流（UDAF）提供局部A级环境，用于无菌灌装、分装等关键工艺，旨在通过物理屏障和工程控制减少人为

For inspections in China, excluding individual inspector-specific factors, what are the main focus points? Is it impurity control or data integrity?

What is the impact of recent U.S. policy changes and FDA reforms on CDMO companies in China?

What will be the biggest impact to the industry due to FDA reduce the workforce？

In FDA's pre-approval inspections (PAIs), what is the proportion of unnoticed inspections?

Does FDA conduct surprise inspections on all Chinese products (including sterile products, oral products, and active pharmaceutical ingredients)? What principles determine surprise inspections and the

Is there a difference in the intensity of FDA inspections in China compared to India?

Will inspections of clinical sites also increase? Will FDA's acceptance of Chinese investigator-initiated trials (IIT) data be affected?

Regarding FDA's recent ban on transporting U.S. citizens' cells to China for cell modification，does this equate to FDA rejecting IND submissions for Chinese cell products in the U.S.?

某公司培养基灌装多次失败，他们灌装的是TSB培养基(胰蛋白酶大豆肉汤)，经0.2um的除菌过滤器过滤。调查显示没有明显的原因，污染的原因可能是什么?

如果一个样品在氯化钠蛋白胨缓冲液中溶解澄清（溶液a），再取溶液a到缓冲液则出现析出（溶液b），那是否可以直接取溶液a，然后冲洗滤膜？还是一

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 impact does the introduction of many young auditors by FDA have on inspections? Has the overall style also changed?

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

Under the new FDA review process, will the frequency and intensity of surprise inspections for Chinese companies be affected? As a Chinese enterprise, how should we respond?