With the further enhancement of regulatory requirements, many mainstream systems on the market do not meet the requirements at the functional level, especially production equipment. What consideration
如何理解权限管理11.10条职责分离原则,即参与GMP活动的用户不得拥有管理权限。QA也是GMP活动的参与者,是否可以拥有管理权限?在公司规模较小,没
For small electronic systems such as pH meters, particle counters, osmometers, etc., what is the current official management trend? Do regulators expect companies to upgrade to fully compliant compute
For AI application systems, does the update of the knowledge base count as a change to the computerized system? If it is merely a plugin tool where AI recognition replaces manual data entry but still
For computerized systems used by a company that have mobile websites or apps, what considerations should be made during the initial validation, or what aspects must be validated?
The quality management system requires that management reviews should cover relevant performance indicators for the computerized system and the process it is used in (quality metrics). What quality me
《中国药典》2025 年版规定无菌检验冲中洗每膜一般不得超过5次,每次100ml,我司某抗生素产品注册标准规定每膜不少于600ml。1、我司是否可继续执行
各位老师: 新药,生物药,美国临床阶段,临床样品,之前已经贴签,已经放行了,样品还在中国,还未运送至美国临床试验中心,但是现在临床部
食品级与化工级辅料需要关联审评吗?是否需要符合GMP附录药用辅料要求?因确实无法达到药用辅料的生产条件与检验要求。
请教下各位大佬,无菌制剂生产所用胶塞在新增供应商时,所开展的清洗效果确认除可见异物外,是否一定需要开展细菌内毒素挑战?如何评估是否需
各位老师 生物药,新药,1期,IND批次都已生产完毕,都已放行。之前中美双报,都已经IND批准,临床试验中国已经启动,美国的虽已获批还未启动
1.药企使用的液体除菌过滤器的过滤工艺验证与病毒灭活去除验证为什么一般情况下都找第三方做验证呢?是以为在药企做有污染的风险吗?还是因为其
在制药和医疗保健机构内,当设计和使用设备和供水系统时,一个重要方面是评估如何避免生物膜的产生。微生物学明确的指出生物膜的形成并非一蹴
Run the cycle at 121°C and you're good to go?在制药和生命科学领域,行业内普遍存在一个认知误区,即认为“达到121°C”就是成功的黄金标准。它被印在标准操
mRNA疫苗申报中国IND,需要生产几批产品进行申报?1批非临床批次,1批临床批次,供2批是否足够?
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