Answer / 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.

Answer / 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

Answer / d.sambireddy

oos-out of specifications and oot-out of trend
this two words regular using all pharma industry

1) When ever we are using OOT controling of our quality
and controling of our process

2)Where ever we are using OOS(suppose in investigation
product is not meets the specification)

we will improve next future quality and avioding mistakes
from analysis and processing

Answer / narendra

OOS- out of specification .it means any result
not meet in specification limit or guideline limit.

Exp.-Limit 95-100 % Result obtain 110 % -OOS

OOT- Out of trend . any product batch made in single time and we analyzed time to time as per stability chart scheduled ,if stability result that is not
within the expected trend, with respect to previous/Initial
station results obtained during a stability study.
EXP.- PARACETAMOL TAB. RESULT -

Month %

0 100
6 95
12 98
24 101
36 97
48 115 - OOT

Answer / arvind mishra alchemist

The two terms out-of-trend (OOT) and out-of-specification
(OOS) results are in many cases confused by pharmaceutical
companies and regulatory agencies. OOT results are defined
as a stability result that does not follow the expected
trend, either in comparison with other stability batches or
with respect to previous results collected during a
stability study (1). OOT results are not necessarily OOS,
but they do not look like a typical data point. Although OOT
results are a serious problem, the scientific literature and
regulatory guidelines do not fully address this issue
Methods for identification of OOT results—the
regression-control-chart method, the by-time-point method,
and the slope-control-chart method—and further compare the
z-score method and the tolerance interval in OOT analysis.
The results highlight the need for issuing a regulatory
confirmed guideline for identification of OOT results for
ongoing stability data.

Answer / v.rambabu

OOS:Out of specification i.e the result does not meet the
pre-established vale it is generally occur in pharmaceutical


OOT:Out of trend i.e the result with in the limit that
means the result is correct but when compared to previous
result it is more it is so many times occur in stability
studies

Answer / b.suresh naidu

OOS-Out of Specification. It means any result obtained out
side the pre defined specefied limit.

OOT-Out of Trend. It means any stability result that is not
within the expected trend, either in comparison with other
stability batches or with respect to previous/Initial
station results obtained during a stability study (Eg. This
may be of batch to batch, pack to pack,etc).Moreover this
is a alert message that may trigger to OOS.

Need: Since the products are human consumable, it may have
impact on the safety of the patient.
By monitoring these, there can be control on the
prodcuts process and can have continous improvement.

Answer / prashant kumar vats

oos means - out of specification if the result goes out of limit from given specification. example if result is 90% or 110% spcification is 95 to 105 % result should not between specicification then oos occures...
oot is out of trend if the result goes out of trend it may be stability or finish product comparw from last batches or stability from last stages industries has its in houses limit for oot ... thnx

Answer / s.goutham

OOS- out of specification .it means any product result was
not in specification limit.

OOT- Out of trend -it means draw trend chart of every
product result for every year.any deviation found it was oot

Answer / ramya

oos means out of specification.It is very useful for pharma industry because if any sample rejects the analyst should prepare an oos form.analyst should inform to supervisor and discuss the procedure what the analyst has followed. repetitions should be done based on company rules.

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