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cGMP

cGMP指动态药品生产管理规范，英文名 Current Good Manufacture Practices的缩写，也译作现行药品生产管理规范。它要求在产品生产和物流的全过程都必须验证。cGMP是国际... 查看详情>

共 64 讨论,7天新增 24 个讨论,30天新增 24 个讨论

综合问题文章百科

kk444555 回复了问题 2023-10-17 21:39 cGMP 数据完整性: 问答 What is “data integrity”?

kk444555: For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate da...

kk444555 回复了问题 2023-10-17 21:40 cGMP 数据完整性: 问答 What is “metadata”?

kk444555: Metadata is the contextual information required to understand data. A data value is by itself meaningless without additional information about the dat...

kk444555 回复了问题 2023-10-17 21:41 cGMP 数据完整性: 问答 What is an “audit trail”?

kk444555: For purposes of this guidance, audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the co...

kk444555 回复了问题 2023-10-17 21:49 cGMP 数据完整性: 问答 How does FDA use the terms “static” and “dynamic” as they relate to record formats?

kk444555: For the purposes of this guidance, static is used to indicate a fixed-data record such as a paper record or an electronic image, and dynamic means tha...

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