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
- 16810 Views
- Aurobindo, Hetero, I also Faced
- E-Mail Answers
Answer Posted / s jagadeesh chandra
This is only a briefe answer.
OOT means out of trend.
Definition:
In case of routene analysis any result of quantitative
chemical test that do not fall with in the defined band in
comparison to a specification.
Investigation:
Investigation procedure is same as that of OOS(Out of
specification).
OOt result in qc laboratory
.
Report with in 24 hours to qa&supervisor.
.
phase I laboratory investigation is carried out.
.
If any laboratory error is identified then it is termed as
assiagnable cause(ie system problem identified,sample
preparation,dilution in correct,improper transfer of
solvent,analyst etc etc...).There are many check points are
there to investigate.The investigator will go through the
check points.
.
After assiagnable cause identification corrective and
preventive action will be taken,and order for re testing
the original sample or another on same or another equipment
(if system performance is suspected).The person other than
who obtain the initial results should re test the
sample.After re testing results are to be evaluated and
conclude the investigation.
Re testing plan:2 sample preparetions to be done and analyse
Different different OOT limits are there for different
different tests.
For more details mail me.
| Is This Answer Correct ? | 16 Yes | 0 No |
Post New Answer View All Answers
how will you do the prep for unstable componds?
What are the primary considerations in extractables and Leachables ?
What is the formula for relative diffrence for standard solution in solution stability in validation?
process of Diclofenac sodium,IP.
How require to perform linearity as per ANVISA? What are the acceptance criteria?
how you confirm the assay method?
why we use Dichlorobenzene.nitrobezine.t-butyldi sulhate.for calibration of gc Head space
What is the purpose of octyl silane columns?
What is the acceptance criteria for moisture balance when calibrated with sodium sulfate
Ratio of Water and Acetonitrile(diluent) is not recommended to use in cleaning method validation,why?
How to compare XRD graphs against standard and carry polymorpism study of API's by powder XRD method?
Why to use propyl paraben in HPLC gradient calibration
what is mean by extactable and leachable study?
In HPLC calibration, caffeine is used as primary standard for wave length calibration due to caffeine is having dual maxima at 273 & 205 nm and one minima at 245 nm. Any body can give reference of these details from any pharmacopeia (with chapter no.) or any other authentic guideline?
What is mean by PDR?
