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Production Checklist

No.
Question
Options
1
Is there any difference present between the actual production/operation process and the Manufacturer’s process?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
2
Does more than one product processed in a single room?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
3
Do any Non-Medical Products processed in the Production area?
Yes
No
N/A
4
Is Yield checked and documented at every step of each process?
Yes
No
N/A
5
Is any provision available for In-Process Control in the production area?
Yes
No
N/A
6
Are all Rooms/Areas labeled which indicates Operation in the process?
Yes
<10% not ok
>=10% not ok
No
N/A
7
Are all Equipment labeled which indicate Operation in the process?
Yes
<10% not ok
>=10% not ok
No
N/A
8
Is the Dust Collection system available at the dry material handling area?
Yes
No
N/A
9
Periodical Microbial Monitoring available in the production areas for conducted susceptible products?
Yes
No
N/A
10
Are each Pipes carrying Distilled/Deionized water sanitized according to the procedure, which indicates limits of Microbial Contamination?
Yes
No
N/A
11
Do any Batch reprocessed from Rejected Products?
Yes
No
N/A
12
Does any Returned Batch converted to Resale, Relabeling, or Bulking?
Yes
No
N/A
13
Does the Production Area thoroughly clean and disinfect, before/after every Batch?
Yes
No
N/A
14
Are all the production process follow the predefined Process Validation of the company?
Yes
No
N/A