四眼原则

玲ckehchhh

微生物检测，菌落计数时，谁有四眼原则？如何规定的？

逸清草堂

何为四眼原则

ejckuo

USP<1117> MICROBIOLOGICAL BEST LABORATORY PRACTICES
For the compendial sterility test that combines criticality of the test and higher risk of misinterpretation of results, it is now a standard practice to have a second analyst perform a contemporaneous evaluation of the sample (in test media) for microbial growth. Nonetheless, applying uncritically a contemporaneous reading by a second analyst (four-eyes principle) for all samples and microbiological tests is not recommended. Precision in counts may vary from one analyst to another (even if they are trained and qualified) as colonies may overlap, swarm over media, etc., allowing for misinterpretation. Microbiology is a “logarithmic science”; sample size is statistically weak and testing procedures have inherent variability. By tolerating no differences in counts, a high number of non-critical deviations will be generated, thus consuming resources unreasonably.

ejckuo

微生物检测是对数科学, 四眼原则不见得适用.

门门

逸清草堂 发表于 2024-6-24 14:08
何为四眼原则

一只青蛙一张嘴，两只眼睛四条腿；两只青蛙两张嘴，四只眼睛八条腿；......懂了吧

老K

逸清草堂 发表于 2024-6-24 14:08
何为四眼原则

可能是要戴着眼镜看吧。

zhcm17

逸清草堂 发表于 2024-6-24 14:08
何为四眼原则

double check

wzzz2008

老K 发表于 2024-6-24 14:54
可能是要戴着眼镜看吧。

谁都不服，就服你

玲ckehchhh

ejckuo 发表于 2024-6-24 14:29
USP MICROBIOLOGICAL BEST LABORATORY PRACTICES
For the compendial sterility test that combines criti ...

您好，老师。具体到规程中描述成由另一位经过培训且合格的分析人员对培养后的微生物进行计数复核可以吗

ejckuo

玲ckehchhh 发表于 2024-6-24 16:29
您好，老师。具体到规程中描述成由另一位经过培训且合格的分析人员对培养后的微生物进行计数复核可以吗

USP<1117> MICROBIOLOGICAL BEST LABORATORY PRACTICES
As an alternative to a contemporaneous enumeration, a contemporaneous verification by a second person that the testing activity is performed correctly may be executed for higher risk tests. A second person could verify, for instance, if the reading of results is correctly executed according to the procedure, if the result on the Petri plate is correctly transcribed onto the GMP recording sheet (i.e., if growth is observed this is captured in the GMP sheet), and if the description of the sample corresponds to the description on the GMP recording sheet. An assessment of the risk due to a misinterpreted result and its impact on patient safety is performed to determine the high risk test outlined above.

ejckuo

根据美国药典，相对于重新计数，经第二人确认没有错误誊写会比较重要。

玲ckehchhh

ejckuo 发表于 2024-6-25 14:10
USP MICROBIOLOGICAL BEST LABORATORY PRACTICES
As an alternative to a contemporaneous enumeration, ...

您好老师，这个内容是不是新添加的？我在网上找了以前版本的药典好像没找到这个描述

玲ckehchhh

ejckuo 发表于 2024-6-25 14:14
根据美国药典，相对于重新计数，经第二人确认没有错误誊写会比较重要。

哦，知道了，谢谢

玲ckehchhh

ejckuo 发表于 2024-6-25 14:14
根据美国药典，相对于重新计数，经第二人确认没有错误誊写会比较重要。

您好老师，您公司有规定吗关于四眼原则，有具体的职业内容吗