Author Topic: OOS  (Read 1256 times)

zora

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  • City: Constantine
OOS
« on: August 05, 2012, 03:06:04 PM »
Dear forum members,

Can you explain  the difference between OOS ,OOT and OOE?

Best regards

Zora

Dan Hoch

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  • City: Chicago
  • Organisation: Protocol Link Inc.,
Re: OOS
« Reply #1 on: August 09, 2012, 02:40:21 AM »
Dear forum members,

Can you explain  the difference between OOS ,OOT and OOE?

Best regards

Zora

OOS and OOT are by their names - Out of Specification and Out of Trend, don't know OOE??

OOS and OOT are explained in FDA guidance:
 http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070287.pdf

does that help?

saash1111

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  • City: Mumbai
Re: OOS
« Reply #2 on: August 10, 2012, 05:52:01 AM »
OOS - Out of specification
OOT - Out of Trend
OOE - Out of expectation.
//-
Thanks & Regards,
Sachin

rama

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  • City: Beirut
  • Organisation: Benta SAL
Re: OOS
« Reply #3 on: October 18, 2012, 11:31:39 AM »
Hi,

OOS means failing of Acceptance criteria, OOT means the results will be within the Acceptance criteria but out side of the expected range. OOT is applicable for the Stability results.

For Ex. if the difference in assay results from the initial to the particular time point is >5%, then it is considered as OOT in stability.

Regards,

Rama

 


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