Out of Specification Investigation Phase II (Unknown Cause / No Assignable Cause ) & Phase III Phase II Investigation – Unknown Cause / No Assignable Cause These are difficult to perform as the result can be 1 to 2 weeks after the analysis was performed and maybe weeks after the batch was manufactured. It is …
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Out Of Specification Investigation Phase II (MHRA) Conducted when the phase I investigations did not reveal an assignable laboratory error. Phase II investigations are driven by written and approved instructions against hypothesis. Prior to further testing a manufacturing investigation should be started to determine whether there was a possible manufacturing root cause. If not already …
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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II) Out Of Specification( OOS ) :- The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification( OOS ). We have seen in last …
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