full name of OOS & OOT ? Dercribe it with details ? why
this is needed in pharma industry ?

Answer Posted / rajender

OOS stands for out of specification, if any batch in plant
doesn't meet the desired specifications because of various
reasons then concern QC will raise out of specification
base on the results, based on the out time OOS we can
perform use test so as to qualify material for next step

OOS can relased before releasing complete intermediate
report

Is This Answer Correct ?    24 Yes 3 No



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

If we do accuracy at same concentration at which linearity planned,what is the need to do linearity separately?

1757


What is viod volume and peak purity in HPLC?

2347


analytical method validation require to with respect to release specification or shelf life specification?

285


is it nessesary to do solution stability for 7 days?

318


What if impurity area in control sample coming more as compared to LOQ level of impurity ?

1148






we can use expired sample for validation and analyst qualification?

306


what is mean by ambient temperature?

351


For standardization of volumetric solutions, acceptance limit for concentration is considered as 10% of nominal concentration and %RSD as NMT 0.2% (for appropriate no. of replicates). But , if %RSD has not met, what should be further action?

1256


Why sodium hydroxide used for maintain pH of phosphate buffer

1843


what is turbidimetric titration?Give 2 examples.

1992


What is diffrence between extractable volume and deliverable volume? Answer pls

3935


My question about gas chromatography sulfur chemiluminsecence detector. I test unknown sample gas by GC-SCD (calibrated ) and the result of *H2S is 279 PPM , *but when I test the same sample with the GC-TCD (calibrated ) the value of *H2S is 2500 PPM . I'd like to inform you that both GCs are calibrated and have very good operation conditions with stable parameters . the question is if the sample gas with higher H2S over detection limits of SCD detector (1000 ppm). why the result it 279 ppm Best regards

1118


if you have given one product then how you determine the impurity in that?

295


which one is better separation in high pressure liquide chromatogram orlowpressure chromato gram in hplc

1730


if you get peak in blank then what require to do?

489