Chromatography Forum

Dear All,

I have to prepare an SOP for the OOS and Out of trend analyis for the stability analysis.

The major point in OOT is to define the OOT results. What criteria is used in the industry for identifying the OOT results.


Please let me know.

Consider the following points .....

Change in Physical properties,pH, etc
significant changes mentioned in the ICH Stability guidelines
Unknown impurties >0.1%,
10% variation in dissolution.

this may not be directly applicable to stability analysis, but in statistical process control the list of criteria below is the formal definition of a "trend":

Individual points above the Upper Control Limit.

Individual points below the Lower Control Limit.

Seven points in a row all above average or all below average.

Seven points in a row increasing.

Seven points in a row decreasing.

Ten out of eleven points in a row all above average or all below average.

Cycles or other non-random patterns in the data.

Two out of three points in a row outside of two standard deviations above the average, or two out of three points in a row outside of two standard deviations below the average.

Four out of five points in a row outside of one standard deviation above the average, or four out of five points in a row outside of one standard deviation below the average.

refer for example to:

http://www.hanford.gov/safety/vpp/spc.htm