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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Out Of Specification Investigation Phase Ia & Phase Ib (MHRA) Phase Ia Investigation Definition: Out of Specification Investigation Phase la investigation is to determine whether there has been a clear obvious errors due to external circumstances such as power failure or those that the analyst has detected prior to generating data such as spilling sample …
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Out of Specification &Out of Trend Investigations (MHRA) Laboratory Analysis Investigations of “Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results” have to be done in cases of: Batch release testing and testing of starting materials. In-Process Control testing: if data is used for batch calculations/decisions and if in a dossier and on …
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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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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) 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). What USFDA guideline says about Investigation of Out …
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