Which types of deviations are followed in pharmaceuial API
manufacturing industry?
Answer / 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
Is This Answer Correct ? | 0 Yes | 0 No |
why use toline in resolution in uv calibration
when we connect the capacitor banks in series with the circuit? 2 144 pH is having unit?
What r the different sop in or plant
human body absorbs maximum amount of nutrients in
difference between RF and correction factor?
Do you think it is possible to rehabilitate?
what is factor?
How can I assign a retest date for solvents e.g. toluene, methanol, etc?
How to perform forced degradation on tablet sample or suspensions?
what is difference between method validation and method verification
What experience do you have in training?
plz.mail me model papers of drug inspector of chhattisgarh..or MP.if Posible. Mail Id-recha_1428@rediffmail.com...mrs_1428@rediffmail.com,