Friday, December 24, 2010

Internal Audit check list for Production department

Internal Audit check list for Production department


Sr. No.
Check points
Observation (Yes/No)
Comments
Recommendation
Action taken by
1.       
Is the control copy of production department SOPs available?




2.       
Are the personnel having knowledge of current GMP requirements?




3.       
Are the lots of raw material properly stored?




4.       
Are the lots of raw material having proper labels of status?




5.       
Is the housekeeping maintained?




6.       
Is the weighting balance having proper tag of calibration status?




7.       
Is the balance calibration record available?




8.       
Are the calibrated standard weights available?




9.       
Is the calibration certificate available?




10.   
Is the standard weights are properly stored?




11.   
Is the reactor area cleaned?




12.   
Is the status label of reactor available?




13.   
Is the BMR requisition slip record available?




14.   
Check the calibration status of temperature gauges.




15.   
Check the calibration status of pressure gauges.




16.   
Check the status of centrifuge.




17.   
Check the cleaning of centrifuge and centrifuging area.




18.   
Check the condition of centrifuge bags.




19.   
Check the status of dryer.





20.   
Check the cleaning of dryer and drying area.




21.   
Check the calibration status of temp, Gauge of dryer.




22.   
Check the trays and trolley condition.




23.   
Check the status of sifter.





24.   
Check the cleaning of sifting area.




25.   
Check the status of multi mill.




26.   
Check the cleaning of milling area.




27.   
Check the finished product packing area.




28.   
Check the availability and stock of packing materials.




29.   
Check the temperature and humidity record.




30.   
Check the cleaning of sampling devices.




31.   
Are all the sampling devices properly stored?




32.   
Check the general cleaning and housekeeping of plant.




33.   
Check the test request slip record.




34.   
Check the personnel hygiene.




35.   
Check the safety equipments.




36.   
Check the other records.




37.   
Is ECR available?





38.   
Check the ECR.





39.   
Check the condition of reactors.




40.   
Are there work instruction labeled on all equipments.




41.   
Are records maintained for Solvent Receipt, Usage & Recovery In Plant?




42.   
Check the records of Solvent Receipt, Usage & Recovery In Plant.




43.   
Is there any training record for new employee?




44.   
Check the training record and training schedule.




45.   
Is the pipeline properly marked with directional arrows?




46.   
Is logbook of all Equipment properly maintained?




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