Dove Research & Anulytics

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Annexure-2
OUT OF SPECIFICATION INVESTTGATIqN REPORT
T OF SPECIFICATION RESULT OBSERVED
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Observation Sign/ :::.:
S.No. Parameters
(Yes/I'{oA[A) Date

1. Anv unusual happening in lab? (e.g' porver failure) NA t*h"l{

2. Was the method discussed with the analyst? YEJ ,r-l rzlt\
J. Corect analyti<;al method used Y€( #-n'r-trt
4. Analyst r.vas trained to perfbrm the test? YEE fu,"ltl
Conect glassware used for dilutions? Yes ki,+r
filurt*or" was proPerlY cleaned? Yes , it,,-\rq
6.
1 Instrument used are qualified? Yes &-r'd,q
8. Is there anY abnotmality or malfunction of Instrument observed? Nlo 1r,Jrt
9. Instrument used w'ithin calibration validity period
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Instrument used (Name & ID) Calibration due ' *.
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10. Instrument setup & operation as per standard operating procedure? Vgs $rndrt
Use of appropriate gracle of chemical and regents rn'ithin the validity Yzr b
11. period'? fl;+ro)\l
12. Correct nortnality/ molarity of I.-
Volumetric Solution used Valid up to date Strength

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 Dove Reseorch & Analytics
Pqnchkula (Hsrysnql

Date: l8ll2ll9
OOS no. DRA/OOS/19/001

INVESTTGATION REPORT
From the investigation it was observed that the Assignable cause is may be of
analyst effor.

1. As per the Investigation it was observed that the main root cause is found
that the eror observed in the sample preparation by the analyst. as per the
test method in related substances test there is no sonication and heat is
required. Inspite of that analyst did perform the sonication and heat in the
sample preparation.
It may be the root cause of the OOS
2. To ensure the possibilities of the existence of this root cause below actions
are required to confirm as per the Investigation held with the Analyst
3. Reperform the analysis with different HPLC on date IBII2/19 after the
training provided to the analyst and reviewer.
4. Section incharge to check the preparation of sample and Senior Analyst also
review the analysis from initial to final results.
5. Compare the results of the Ist Analyst and IInd Analyst and evaluate the
clear Root cause.
6. In the second analysis result meets the acceptance criteria i.e. NMT 01%
than it is clearly indicates a laboratory eror.
7. For the verification of the results observed by the second analysis (IInd
analyst) we have again execute the third analysis as per the same test method
and the observed results are comparable as well as complies with the results
of the second analysis, Therefore it is now cleared that the main cause was in
the first analysis where analyst used a sonication and heat additionally (as
described above in point no.1) which were not provided in the test method.
Therefore the OOS is found Invalid.

prepared or, Checked by:

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