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In pharmaceuticals formulation OOS applicable in Raw
Material(which is not manufacturing in the company. and
purchase by approved vendor)).Why?
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Answer / b.suresh naidu
Yes OOS is applicable in Raw materials (which is not
manufacturing in the company and purchased by approved
vendor).
OOS may be due to assignable (or) non-assignable causes,
which may occur due to analytical error, manufacturing
error, _ _. To identify the root cause, investigation
should be done.
In a formulation unit, upon observation of OOS in any Raw
material, preliminary investigation/retesting to be done as
per ‘In-house OOS’ procedure (The procedure should be
clearly defined in ‘In-House OOS’ SOP). The OOS should be
informed to the Vendor on the day of the
observation/Confirmation. It is the responsibility of the
Vendor to do further investigation (Vendor should have
their OOS procedure for OOS investigation).
Upon completion of investigation, the Vendor should
inform the same to the respective Formulation unit with
necessary CAPA.
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