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

Answer Posted / saritha

oos-out of specifications and oot-out of trend
oos for pharmaceutical products
oot for occur when a stability result does not follow the
expected trend, either in comparison with other stability
batches or with respect to previous results collected
during a stability study.

Is This Answer Correct ?    48 Yes 5 No



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

[3/28, 20:52] Manoj P Venkatpurwar: how many impurities require to inject in assay specificity that how we can find out? and in Rs also how?

353


What is split ratio in Gc? Splitless? how requirr to select?

325


For limit test of heavy metals in BP, Method C require that the substance is ignited at a temperature not exceeding 800 °C. Why confines such the temperature?

3500


what are the guidelines for analytical method validations?

597


why lactose has less charges when packed in steel containers when compared with packing of lactose in polyamide material?

1768






How to calibration of the uv spectroscopy and its test?

673


acceptance criteria for lod & loq by standard deviation of response and slope??

2095


identification is for unknown? qualification for known? reporting for LOQ?

288


What is column in chromatography?

1761


How can the GC or HPLC method is selected to determine the impurity profile in drug product?

6867


In which situation we require to analytical method validation of excipient?

297


How you develop a method in HPLC?

2079


if rsd failed then what require to do?

326


Which are the diffrent grades of api in pharma?

317


Principle of single pan analytical balance

4604