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Which types of deviations are followed in pharmaceuial API
manufacturing industry?
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Answer Posted / sunil sharma (joping)
Deviations are measured differences between observed value and expected or normal value for a process or product condition, or a departure from a documented standard or procedure.
There are two types of Deviations
Planned deviation and Unplanned deviation
Planned deviation: Planned deviation shall always be approved before execution of deviation.The documentation (before approval) should include the parameters to be monitored during execution of deviation.The quality of final output shall be checked & compared with regular process.
While closing the deviation, it should be evaluated for effectiveness, whether the purpose of taking deviation is achieved/not. If not, such deviation in future shall be avoided.
If the deviation is as per the exception the same can be considered for regularization.
After briefing on all the above points deviation shall be closed.
Unplanned Deviation: Any deviation occurred unplanned manner due to system failure or system breakdown or manual error shall be termed as Unplanned deviation
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