Sr. No. | Check points | Observation (Yes/No) | Comments | Recommendation | Action taken by |
01 | Is the control copy of QC department SOPs available? | | | | |
02 | Are the personnel having knowledge of current GMP requirements? | | | | |
03 | Is the housekeeping maintained? | | | | |
04 | Is the weighting balance having proper tag of calibration status? | | | | |
05 | Is the balance calibration record available? | | | | |
06 | Are the calibrated standard weights available? | | | | |
07 | Is the calibration certificates available? | | | | |
08 | Is the standard weights are properly stored? | | | | |
09 | Are the status labels available on each instrument? | | | | |
10 | Is the instrument calibration record available? | | | | |
11 | Check the temperature and humidity record. | | | | |
12 | Check the cleaning record. | | | | |
13 | Check the cleaning of sampling devices. | | | | |
14 | Are all the sampling devices properly stored? | | | | |
15 | Lab and storage areas uncluttered (i.e. aisles and exits free from obstructions). | | | | |
This Blog is created for the updation of knowledge on Quality Assurance, current Good Manufacturing Practices (cGMP) and current Updates from all regulatory authorities. Also one can archive Standard Operating Procedures (SOPs), specification and pharma jobs etc. for any Pharma plant.
Friday, December 24, 2010
Internal Audit check list for QC department
Internal Audit check list for QC department
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