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所有你需要知道的关于设备验证无菌测试的验证

James E T Gebo1, Kayla M Feehely1, Chase E Lattimore1

  • 1Sterility Testing Service, Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.

Journal of clinical microbiology
|August 11, 2025
PubMed
概括

临床实验室在当前的良好制造实践 (cGMP) 下面临产品无菌性测试的挑战. 本审查详细介绍了设备,软件和系统验证 (安装,运行和性能合格 - IOPQ) 以满足FDA的要求.

关键词:
IOPQQ 的意思是cGMP的良好使用情况.细胞疗法是细胞疗法.设备 设备 设备 设备资格资格资格资格资格资格无菌性测试是一种无菌性测试.验证验证的时间

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