Interested to Buy Any Domain ? << Click Here >> for more details...
As per OOT for any product what is calculation and how to
invetigate the OOT
- 3 Answers
- 17007 Views
- Aurobindo, Hetero, I also Faced
- E-Mail Answers
Answer Posted / vamsidhar reddy. b
1. Tabulate the data, calculate the average and standard deviation.
• Use excel spread sheet for average & Standard deviation calculation.
• Standard deviation will be multiplied by 3 to get the 3 sigma (3 )) value.
• Calculate ± 3 Sigma
• Maximum & Minimum limits will be fixed by the formula Average ±3 Sigma
• If the obtained maximum value is above the spec. Limit, specification limit shall be taken into consideration.
• The obtained minimum value may be below the lower spec. limit.
• The maximum and minimum limits as explained above shall be taken as the trend range for upper and lower limits.
• Any obtained value is found to be out of this range will be considered as Out of Trend (OOT) value.
2. Based on preliminary investigation OOT Results should be reconfirmed with same analyst in duplicate.
3. If the result of repeated analysis is in line with the result of 1st analysis, then results of 1st analysis shall be reported and 2nd analysis is considered ‘For confirmation only’ and further investigation is carried out for the cause of OOT result.
4. If the result of repeated analysis is line with previous trend, then result of 2nd analysis shall be reported and no further investigation is carried out with respect to the product.
| Is This Answer Correct ? | 1 Yes | 0 No |
Post New Answer View All Answers
how to select short coloum and long coloumn for new molecule
why glutent are detected in the rice cereal baby food product even manufacturer claimed that they are using rice and milk only?we have using ELISA to do the test,and rice supposed not containing any glutent,rite?We already repeat the test so many times and it still detected.just wondering where the glutent came from?
what is biorelivent dissolution media?
Which products will produce when acetic anhydride reacts with Ter-butanol, Sec-butanol, Iso butanol, Dimethylamine etc.
analytical method validation require to with respect to release specification or shelf life specification?
What is importance of pH in the Heavy metal test and How it effect on the test results?
what is difference in ods I ods II is this is realy from sorbent / packing characteristics or from other means
what is partion and column chromatography
how require to interprit the method precision data of hptlc?
In the isomers,enantiomers give the only physical properties present such that no chemical properties present.
what is procedure of actual procedure for registration of drug?
In GC calibration,what is the procedure to calibrate the TCD (thermal counductivity detector)suggest ?
in api coa contains only process impurities and in product coa contains degradation impurities?
How to calibration of the uv spectroscopy and its test?
all types of questions asked at the cipla interview
