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发表于 2021-12-6 11:22:01
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指的是第二人复核。
Verification by a second individual
The four eyes principle is a cornerstone of any quality system — GMP, Good Laboratory Practice (GLP) or International Organization for Standardization (ISO) 17025. A first person performs a task, and then a second person checks it. In U.S. GMP, there are several references to a second-person check or verification, such as QC analysis for the laboratory (§211.194). These second-person checks are all key stages of the pharmaceutical manufacturing process. They are to ensure that mistakes can be caught and resolved early in the process. Although this is primarily to ensure patient safety and compliance with the regulations, it is also good business sense as well, since you don’t want to commit resources to a process that will fail. |
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