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DEPARTMENT:
QUALITY ASSURANCE DEPARTMENT
TITLE :
HANDLING OUT OF SPECIFICATION
1.0
PURPOSE
To describe procedure for Handling Out Of Specification (OOS).
2.0
SCOPE
This SOP shall be applicable to all OOS test results of Raw and Packaging Materials, In
Process Materials, Finished Products and Stability Samples at PEGASUS, Bhongir.
3.0
RESPONSIBILITIES
3.1
3.1.2
3.1.3
3.1.4
3.1.5
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
3.2
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
2 of 12
3.2.2
3.2.3
3.2.4
3.3
4.0
LIST OF ATTACHMENTS
Annexure - 1: Format for OOS Logbook
F/PB/QAD/032/24
Annexure - 2: Department code for OOS
NA
NA
NA
Reviewed By:
Date:
M. RAJAREDDY
(Incharge QC)
F/PB/QAD/032/27
Approved By:
Date:
A. K. BHATTACHARYA
(Manager QA)
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
5.0
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
3 of 12
PROCEDURE
5.1
Frequency:
Immediately on being aware of OOS results or within 1 or maximum 2 days after
completing analytical test (After being checked, audited and reviewed by immediate
supervisor).
5.2
Introduction:
OOS results obtained in the laboratory fall into three general categories:
5.2.1
Laboratory error
5.2.2
5.2.3
When an individual test result does not meet the specifications, it need not
necessarily indicate that the batch has failed. The cause of the OOS result should be
investigated adequately and thoroughly and in time. The results of such an
investigation should be documented. Corrective and preventive actions must be taken
and should be reviewed during batch release.
Phase - I means the Laboratory OOS investigation and Phase - II means the Full
scale OOS investigation.
Prepared By:
Date:
SWATHI. KOTLA
(Officer QA)
Reviewed By:
Date:
M. RAJAREDDY
(Incharge QC)
Approved By:
Date:
A. K. BHATTACHARYA
(Manager QA)
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
5.3
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
4 of 12
When any OOS test result is obtained, log the OOS entry in the OOS log
book as per Annexure - 1.
The numbering system for OOS shall be as follow:
PB / OOS / XXX / YY / NNN
PB
OOS
XXX
YY
NNN
i.e. PB/OOS/XXX/QCD/13/001
indicates that this is the first OOS raised by the QC department of the
Pegasus, Bhongir.
5.3.2
When instruments have been used, check whether they have been calibrated
and were suitable at the time of use.
5.3.3
5.3.4
Retain all test preparations and check the raw data for any clear mistakes
such as incorrect preparation, dilution, injection or storage, inappropriate
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
5 of 12
Check whether any deviations had been noted during the time of Analysis
and whether they were recorded in the worksheets.
5.3.6
5.3.7
5.4
Carry out the assessment of the OOS result as soon as the result is
reported.
5.4.2
Discuss the test method with the analyst to confirm that the analyst had
performed the test procedure correctly.
5.4.3
Examine the test data sheet and accompanying attachments in order to find
out whether the results can be attributed to laboratory error.
5.4.4
Prepared By:
Date:
SWATHI. KOTLA
(Officer QA)
Reviewed By:
Date:
M. RAJAREDDY
(Incharge QC)
Approved By:
Date:
A. K. BHATTACHARYA
(Manager QA)
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
5.4.5
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
6 of 12
5.4.6
5.4.7
5.4.8
5.4.9
5.4.10
5.5
If clear error has occurred, arrange for the retesting of the second aliquot of
the same sample solution or aliquot prepared from the same portion of the
original sample by the same analyst in triplicate.
5.5.2
If all the three results of retesting are within the specification, average it,
and substitute the average result for the initial test result (ensure that the
Prepared By:
Reviewed By:
Approved By:
Date:
Date:
Date:
SWATHI. KOTLA
M. RAJAREDDY
A. K. BHATTACHARYA
(Officer QA)
(Incharge QC)
(Manager QA)
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
7 of 12
averaged results are within the proven and acceptable range) and record it
along with an explanation for the initial analysis failure (Genuine lab error reversible error). Invalidate and disregard the previous results on knowing
the probable cause of error, (Record and file the observations with
signature) Retain all the data together.
Statistical acceptance criteria:
The percentage RSD of 3 replicate determinations should not exceed the established
precision for the test.
If immediate supervisor analyst investigation is inconclusive then Situation II:
(Inconclusive error retest):
5.5.3
If the result of retesting is outside the specification and there is no clear
error, arrange for the prompt retesting in replicates by a 2 nd analyst (with
higher experience of testing) using the additional portion of the original
sample. Involve Quality Assurance/Production to look at quality trend of
other batches for the same test to have an idea whether the results of the
earlier batches are within the proven and established range.
5.5.4
Prepared By:
Date:
SWATHI. KOTLA
(Officer QA)
Reviewed By:
Date:
M. RAJAREDDY
(Incharge QC)
Approved By:
Date:
A. K. BHATTACHARYA
(Manager QA)
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
8 of 12
ascertaining the cause of error (sample integrity being biased); document the
investigation with the signature.
5.5.5
When the initial test and retest on the same sample produces the
OOS
results, determine whether it is possible that the original Sample was nonrepresentative of the whole lot and requires re-sampling.
5.5.7
5.5.8
Prepared By:
Date:
SWATHI. KOTLA
(Officer QA)
Reviewed By:
Date:
M. RAJAREDDY
(Incharge QC)
Approved By:
Date:
A. K. BHATTACHARYA
(Manager QA)
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
9 of 12
If the OOS is not sorted at laboratory stage i.e. Phase - I, then Full scale
OOS investigation of production process review is required i.e. Phase - II.
Prepared By:
Date:
SWATHI. KOTLA
(Officer QA)
Reviewed By:
Date:
M. RAJAREDDY
(Incharge QC)
Approved By:
Date:
A. K. BHATTACHARYA
(Manager QA)
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
5.6
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
10 of 12
When the initial assessment does not determine that laboratory error caused
the OOS result and testing results appear to be accurate, a full-scale OOS
investigation is required. This investigation may consist of a production
process review and/or additional laboratory work. The objective of such an
investigation should be to identify the root cause of the OOS result and take
appropriate corrective and preventative action. A full-scale investigation
should include a review of production. Such investigations should be given
the highest priority.
5.6.2
Full scale OOS investigation should be carried out when a product does not
meet the approved specification or any unusual observations are made
during the process of storage, handling, manufacturing or testing of the
product and /or initiated by any of the following conditions.
5.6.2.1 OOS investigation (not due to analytical error)
5.6.2.2 Market complaint.
5.6.2.3 Product recall.
5.6.3
5.6.4
5.6.5
Prepared By:
Date:
SWATHI. KOTLA
(Officer QA)
Reviewed By:
Date:
M. RAJAREDDY
(Incharge QC)
Approved By:
Date:
A. K. BHATTACHARYA
(Manager QA)
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
5.6.6
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
11 of 12
Head QA shall hold the release of the batch during investigation of the
subjected batch. Such batch should be quarantine and should not be released
for dispatch, till investigation is complete and a decision is made.
5.6.7
5.6.8
5.6.9
5.7
Corrective Actions
5.7.1
5.7.2
Prepared By:
Date:
SWATHI. KOTLA
(Officer QA)
Reviewed By:
Date:
M. RAJAREDDY
(Incharge QC)
Approved By:
Date:
A. K. BHATTACHARYA
(Manager QA)
Issue Date:-05.07.2014
Effective Date
01.08.2014
Review Date
31.07.2016
TITLE :
HANDLING OUT OF SPECIFICATION
6.0
Rev. No.
SOP No.
PB/SOP/QAD/032/00
Supersedes
NEW
Page No.
12 of 12
REVISION HISTORY:
Effective Date
Prepared By:
Date:
SWATHI. KOTLA
(Officer QA)
Reviewed By:
Date:
M. RAJAREDDY
(Incharge QC)
Approved By:
Date:
A. K. BHATTACHARYA
(Manager QA)