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SOP on Handling of Out of Specification Results in

quality control  December 12,  QA & Q, Quality Assuranc ,
 Pharma Edito 2016 SO
on SOP on Handling of Out of Specification Results in quality  3,924
 Comments Offcontrol Views
OBJECTIVE
To lay down a procedure for handling of Out-of-Specification (O.O.S.) test results generated during the testing.
SCOPE
These procedures are applicable to all QC testing of raw materials, finished product, and stability samples.
RESPONSIBILITY
Analyst/ Quality Assurance Manager
ACCOUNTABILITY
Quality Assurance Manager
PROCEDURE
All out-of-specification test results (i.e. suspected test results that fall outside the established specifications or acceptance criteria) shall be
investigated.
When an Out-Of-Specification test result is generated/ suspected, the analyst shall inform to the QA Manager immediately about the test
results.

OOS number shall be allocated in the following manner. OOS/YY/XXX, where OOS represent the Out of specification, YY indicates the last
two digits of the year & XXX indicates the serial number from 001 to 999. Enter the details in Log Book for out of specification results as per
Annexure –I.

QA Manager will assess the data based on investigation to ascertain if the results can be attributed to laboratory error, or whether the
results indicate problems in the manufacturing process.

Accordingly, the investigation Phase I and/ or II (Phase-I and II investigation relates to laboratory error and investigation of problems in
manufacturing process, respectively) will be decided.
Phase-I Investigation

Both analyst and QA Manager are responsible for completing the Phase-I investigation (Annexure-II).
The first part of this investigation shall be an initial assessment of the accuracy of laboratory’s data (i.e. finding of an assignable cause, as
per Annexure-I), before any test solutions are discarded.
Re-testing on the retained test solutions/ standard solutions shall be performed immediately by the same analyst who performed the
original test, (For this purpose, all original test solutions shall be preserved until calculation of test results is done).

If clear evidence of laboratory error exists and the cause of OOS can be assigned to this laboratory error (like sample preparation, analytical
method followed, equipment malfunctions etc.) In this case the original O.O.S result may be invalidated. The cause of OOS shall be
documented, and the subject batch may be released.
If the initial O.O.S. results are not assigned to original solutions of test preparations, analyst error, equipment malfunction etc., retest from
the original portions of sample drawn may be performed after due authorization by QA Manager. Re-testing shall be done (in triplicate) by
the analyst other than the one who has performed original test.
If none of the three results obtained is out of specification, results may be averaged. The RSD of the triplicate results should not be more
than 3%.
If such retest results meet the specifications, cause of original O.O.S. must be investigated and documented. If the cause can be assigned to a definite
Analytical error with specificity to certain area of retesting, and the O.O.S. is not related to manufacturing process, then original O.O.S. may be
invalidated.
Depending upon the nature of Analytical error, a review shall be performed, if such errors have past history. Accordingly, review of Analytical method,
equipment calibration or re-training / revalidation of Analyst shall be performed.
Complete review of this investigation shall be documented, to minimize reoccurrence of such incidents in future.
Re-sampling may be permitted, by Manger-QA, only if, retest data from same original portion of the sample have been evaluated and the subsequent
investigation gives possible evidence in respect of errors in sampling. (e.g. Non-representative ness of the original sample is indicated by wide variation
in results from several aliquots of the original sample).
Re-sampling, if permitted, shall be performed using the same sampling procedure.
Evaluation of data from re-sampled material shall be performed to determine if original sample was not representative. If there is adequate evidence to
support error in initial sampling (like contamination from sampling tool or wrong identification or sampling from damaged container etc.), and if it is
established that original O.O.S. result was due to faulty sampling or errors in sampling procedure, then only the original O.O.S. result can be invalidated.
Testing of re-sampled aliquot shall be performed by the same analyst who performed the original analysis and with the same sampling method, in
triplicate to establish new basis for batch release.
If 3 such data meets specifications individually and RSD of data is within 3% limit, original O.O.S. result is invalidated, and batch may be considered for
release. While taking such decision, it should adequately be established that there are no failures in Manufacturing Process.
If out-of-specification test results are generated in Disintegration, Dissolution, and Uniformity of dosage units tests, and the cause is nonassignable, then
applicable Pharmacopoeia (USP/BP/EP/IP) procedure shall be followed.
All steps leading to O.O.S. investigations shall be documented and review of each failure shall be correlated to occurrence of similar failures in the past.
An action plan shall then be prepared, depending upon the nature of failure found which caused O.O.S.
If no assignable cause is found till this stage, the original results shall be considered VALID and the subject batch shall be REJECTED.

For further detailed investigation into O.O.S. result, Phase II investigation shall be initiated to determine the cause of Failure in the manufacturing
process.
Phase – II Investigation
It should be carried by a Group consisting of, Manager QA, Manager Production and Manager Pharma Technology & Development (PTD) (If required).
(Annexure – II)
This phase shall also take into account the complete evaluation of Batch Process Records related to the subject batch.
It shall cover complete review/ evaluation into potential manufacturing causes of the O.O.S result and it’s impact on preceding or succeeding batches of
this product.
Trend analysis of previous batches shall be reviewed, if there is any evidence to indicate Failures prior to observation of O.O.S. result and also to assess
the impact of Failure on previous batches. (Phase II investigation may also be performed parallel to Phase I investigation)
Investigation and resolution of all O.O.S. test results is a priority matter and hence Phase-I investigation should be completed within 72 hours. In case of
a confirmed O.O.S. Result, Phase II investigation to identify the cause of Failure should be completed within 30 days and an Action Plan (to prevent the
re-occurrence of the similar test results) should be circulated to all concerned departments.

Forms and Records (Annexures)

OOS log book – Annexure-I
Phase –I & II investigation report – Annexure-II
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering History
Date Revision Number Reason for Revision

– 00 New SOP

Annexure-I

OOS log book

 Whether any spillage of material noticed during processing:
Any other deviation in the batch, if so, give details thereof :
Whether the Environmental conditions, specified for the : process are followed.
Whether the storage container is suitably stored at the : designated place, at different stages of the manufacturing.
Give details of the storage time at different stages.
Reconciliation of yield at various stages. If not meeting : the standard, then state the reason thereof.
NON-PROCESS RELATED
Whether any malfunctioning of equipment is noticed :
Whether any power failure occurred for extended period during : the manufacturing
Other observations (if any) :
Conclusion of Investigation (Brief here):

If investigation reveals any process problem, then give report/comment of PRD Head*:
Trend analysis of the previous batches*:
Impact of O.O.S. test results on Preceding and Succeeding batches of the product*:
* Attach additional sheets, if required.
Investigation Report Completed by :

Name

Signature

date Manager – Production 1 PRD Head (if applicable) QA Manager

Investigation Report Approved by :

Action Plan circulated : Yes/No
QA Head
Sign & date :

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