What is the procedure for investigation of an OOS (Out of
specification) results?
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Answer / b.suresh naidu
OOS may be due to assignable cause (or) Non-assignable
cause.
Assignable cause: It means error is identified.
Non-assignable cause: It means error is not identified.
When any OOS result is observed, first to know any
assignable cause Laboratory preliminary investigation
(Phase-I) is recommended. Phase I investigation should
contain whether correct methododology followed as per STP,
used calibrated instruments,Analyst trained & re-injection,
re-filtration, re-dilution, re-sonication from the
original stock solutions, _ _ _etc).
If any Laboratory error is identified then repeat analysis
as defined in the SOP [Min it should be NLT 6 replicates by
two different analysts (preferably Original analyst &
experienced analyst)]
If no Laboratory error is identified, then full scale
investigation (Phase-II) is recommended. Phase-II
investigation should contain atleast Manufacturing,
Packaging, sampling/re-sampling, _ _ _etc.This sholud be
clearly defined in the SOP.
If any assignable cause is identified then repeat analysis
as defined in the SOP [Min it should be NLT 6 replicates by
two different analysts (preferably Original analyst &
experienced analyst)].If no assignable cause is identified
in phase-II investigation, then further investigation/
batch disposition shall be done as recommended by QA.
Further more details refer CDER guidelines from USFDA.
| Is This Answer Correct ? | 35 Yes | 1 No |
Answer / rams
OOS Investigation done by groupleader ,firstly wether check
analyst follow the correct STP ,check the analysis he is
done e.g. he used proper cleaned glassware and correct
working standard ,he used calibrated system like Ph
meter,Dissolution,HPLC and also correct dilutions .If he
done correct analysis,then give same sample for 2nd analyst
for OOS analysis.
| Is This Answer Correct ? | 16 Yes | 5 No |
Answer / ramya
when oos arises inform to the supervisor and discuss the analyst procedure whether they followed wrong or right.if right then repeat the analysis by different analysts.then also result is same means inform to manager and QA DEPT.Get approval from QA and fill the form with obtained results.
| Is This Answer Correct ? | 2 Yes | 3 No |
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