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Weighing And Dispensing Area – Checklist

No.
Question
Options
1
Are the Weighing and Dispensing area separated from other rooms by walls or other partitions and equipped to avoid cross-contamination?
Yes
No
N/A
2
Are all the Weighing Utensils cleaned and sterilized, before/after every use?
Yes
No
N/A
3
Are all the Weighing Utensils Stored in a secured place to avoid contamination?
Yes
No
N/A
4
Are all the Raw Material Containers which will be weighed are cleaned and disinfected before opening it?
Yes
No
N/A
5
Are the Containers well sealed after the weighing process complete?
Yes
No
N/A
6
After weighing, for each Batch, are all the Raw Materials identified and separated based on their identification data?
Yes
No
N/A
7
Are the Scales and Balances used for Weighing, calibrated regularly?
Yes
No
N/A
8
Are all the Results of Calibration properly recorded and documented?
Yes
No
N/A
9
Are at least two Individual Staff available to verify the correctness of the identity and amount for measured or weighted materials?
Yes
No
N/A
10
Is an authorized system available to governing the issuance of Starting Materials, Intermediate, and Bulk products?
Yes
No
N/A
11
Are only required Raw Materials, Intermediate, and Bulk Products available in the dispensing area?
Yes
No
N/A
12
Are the written procedures available for Handling, Weighing, Counting, and Dispensing Raw Materials?
Yes
No
N/A
13
Are the written procedures available for Handling, Weighing, Counting, and Dispensing Packaged Products?
Yes
No
N/A
14
Before Weighing and Dispensing are all the Container of Raw Materials checked for proper Labelling, which includes approval from the QC team?
Yes
No
N/A
15
Are all the dispensed Raw Materials, Intermediate, and Bulk Products rechecked for accuracy, and signed by the supervisor, before sending those to Production?
Yes
No
N/A
16
Are all the unused Raw Materials, Packing Materials, Intermediate, and Bulk Products will be returned to storage only after proper documentation and reconciliation?
Yes
<10% not ok
>=10% not ok
No
N/A
17
Are the return to Storage of all the unused Raw Materials, Packing Materials, Intermediate, and Bulk Products will be rejected if any mismatch in the reconciliation occurs?
Yes
<10% not ok
>=10% not ok
No
N/A
18
Are adequate Staff available in the Weighing and Dispensing area?
Yes
No
N/A
19
Are the proper supervision available for the Weighing and Dispensing area?
Yes
No
N/A
20
Are all the staff of the Weighing and the Dispensing area got the required and updated Training?
Yes
<10% not ok
>=10% not ok
No
N/A
21
Are all the Personnel available at the Weighing and Dispensing area wearing protective clothing and equipment(Uniforms, Gloves, Mask, etc.)?
Yes
No
N/A
22
Are adequate Light Fitting, Pipework, Ventilation, and Other Services available and functional in the Weighing and Dispensing area?
Yes
<10% not ok
>=10% not ok
No
N/A
23
Do the required Humidity, Temperature, etc. maintained and recorded for the area?
Yes
No
N/A
24
Are there Equipment available and functional to regulate the required Humidity, Temperature, etc.?
Yes
No
N/A
25
Are the Weighing and Dispensing area clean and disinfected periodically?
Yes
No
N/A