PEOPLE ALSO READ: Audit Checklist for Store Department
Sr.
No. |
Check
points |
Observation |
Recommendation |
Action taken
by |
01 |
Is the control copy of QC department
SOP’s available? |
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02 |
Are the personnel having knowledge of
current GMP requirements? |
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03 |
Is the housekeeping maintained? |
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04 |
Is the weighting balance having proper
tag of calibration status? |
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05 |
Is the balance calibration record
available? |
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06 |
Are the calibrated standard weights
available? |
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07 |
Is the calibration certificates
available? |
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08 |
Is the standard weights are properly
stored? |
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09 |
Are the status labels
available on each instrument? |
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10 |
Is the instrument calibration record
available? |
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11 |
Check the temperature and humidity
record. |
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12 |
Check the cleaning record. |
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13 |
Check the cleaning of sampling devices. |
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14 |
Are all the sampling devices properly
stored? |
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15 |
Check the general cleaning and
housekeeping of QC. |
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16 |
Are the specifications available for
raw material, packing material, in-process samples, intermediates and
finished products? |
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17 |
Check the in-process testing record. |
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18 |
Check the raw material testing record. |
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19 |
Check the final product testing record. |
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20 |
Check the stability record. |
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21 |
Check the stability chamber record. |
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22 |
Check the solution preparation and
standardize record. |
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23 |
Check the control sample record. |
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24 |
Check all instrument log book. |
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25 |
Check the primary standards and its
storage. |
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26 |
Check the mobile phase status of GC and
HPLC. |
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27 |
Check the HPLC column record. |
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28 |
Check the test request slip record. |
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29 |
Check the personnel hygiene. |
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30 |
Check the safety equipments. |
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31 |
Check the other records. |
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32 |
Check the environment where control
sample store?. |
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33 |
Is log book of destruction of control
sample is maintained? |
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34 |
Is the out of calibrated instrument
well labeled? |
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35 |
Is QC Chemist validated? |
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36 |
Is the sample in QC lab well labeled? |
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37 |
Are the personnel following GLP? |
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38 |
Are training given to new
personnel? |
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39 |
Are all QC personnel in proper dress
code? |
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40 |
Is glassware breakage log book
maintained? |
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41 |
Check DM water analysis record. |
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42 |
Check reference standard records? |
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43 |
Is proper sampling plan available? |
PEOPLE ALSO READ: SOP for Internal Audit
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