top of page

OOS investigation step: Double-check with another lab

Updated: Jun 28

You may fall into an OOS investigation, when even after a thourough expedition, you have doubts if your lab does something wrong, or you have a flaw in your batch.


Instead of having second or third thought and a lot of bitter re-tests, send your sample to another lab - especially when the related analytical method is a not too complex one.


With this solution you can spare a lot of internal resources and valuable time, and you will get a relatively quick answer to your question, and continue your investigation in the good area - either in QC, or in the manufacturing area.

1 view0 comments

Recent Posts

See All

PQR, QMR, CPV, VMP/VMR, Computerized systems' periodic reviews, who knows what else...we manufacture these summaries, but exactly what for? Sometimes we spend so much time compiling these documents th

I just received a question that looked easy at first, but the laws and guidelines are surprisingly vague on this topic. The question is: how to choose between retest period and shelf-life for an API (

bottom of page