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What is the procedure for investigation of an OOS (Out of
specification) results?
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Answer Posted / 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.
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