微生物OOS处理

wangyp2810

如果微生物检测出现OOS，应该如何处理？在哪能找到相关参考资料，谢谢！

xmango

微生物超标一般不适用于普通的oos，一般叫mdd
usp有个关于这方面的专论。查了一下是这个USP<1117>专论《Best Microbiological Practice》

工作QQ

an investigation into the microbial data deviation (MDD) is required. There are generally two distinct reasons for the observation of microbial contamination that does not comply with a target or requirement: There may be either a laboratory error or laboratory environmental conditions that produced an invalid result, or the product contains a level of contamination or specific types of contaminants outside established levels or limits. In either case, laboratory management and, in most cases, the Quality Unit should be notified immediately.
A full and comprehensive evaluation of the laboratory situation surrounding the result should be undertaken. All microbiological conditions or factors that could bring about the observed condition should be fully considered, including the magnitude of the excursion compared to established limits or levels. In addition, an estimate of the variability of the assay may be required in order to determine whether the finding is significant.
The laboratory environment, the protective conditions in place for sampling, historical findings concerning the material under test, and the nature of the material, particularly with regard to microbial survival or proliferation in contact with the material, should be considered in the investigation. In addition, interviews with the laboratory analyst(s) may provide information regarding the actual conduct of the assay that can be valuable in determining the reliability of the result and in determining an appropriate course of action. If laboratory operations are identified as the cause of the nonconforming test outcome, then a corrective action plan should be developed to address the problem(s). Following the approval and implementation of the corrective action plan, the situation should be carefully monitored and the adequacy of the corrective action determined.
If assay results are invalidated on the basis of the discovery of an attributable error, this action must be documented. Laboratories also should have approved procedures for confirmatory testing (retesting), and if necessary, resampling where

albertchen

学写了!!!!

liuqygood2005

学习了，多谢！

susanliu

学习了，多谢

wangyp2810

工作QQ 发表于 2015-12-11 18:29
an investigation into the microbial data deviation (MDD) is required. There are generally two disti ...

英语没学好

pxt33

可以看中国药典四部附录9203最后有

大草原制药人

参照FDA指南也有。

seamen

大草原制药人 发表于 2015-12-16 10:20
参照FDA指南也有。

文件具体名称有吗？

yuanyi58

工作QQ 发表于 2015-12-11 18:29
an investigation into the microbial data deviation (MDD) is required. There are generally two disti ...

请问 这出出是哪里