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Production Area Checklist

No.
Question
Options
1
Are Separated Area designated and labeled for the production of different categories ( such as Antibiotics, Beta-Lactam, Steroids, etc.), which eliminates the risk of cross-contamination?
Yes
No
N/A
2
Are all the Premises designed in such a way in the production area which justified the flow of the material?
Yes
No
N/A
3
Whether the Access to the production area restricted to authorized personnel only?
Yes
No
N/A
4
Are all the Walls, Floors, and Ceiling smooth and damp/crack-free?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
5
Are Production Areas hard, smooth, and impervious, which allows handling the dangerous materials and also makes the cleaning and sanitization easy?
Yes
No
N/A
6
Is adequate working space available in the Production Area?
Yes
No
N/A
7
Is at least one-meter space provided, around for each Equipment in the Production area?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
8
Are adequate light fittings, pipework, ventilation, and other services available and functional in the production area?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
9
Are all the Service lines and Light Fittings concealed and accessible from the outside?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
10
Are all the Service lines and Lights in well-working conditions?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
11
Is proper Ventilation system with air-control facilities available in the Production area?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
12
Do the required Humidity, Temperature, Filtration, etc. maintains and recorded for the area?
Yes
No
N/A
13
Are there Equipment available and functional to regulate the required Humidity, Temperature, Filtration, etc.?
Yes
No
N/A
14
Are all the Data for regulation well documented?
Yes
No
N/A
15
Are the Drains of the production area has adequate size, sufficient in number, and suitably located to prevent the backflow?
Yes
No
N/A
16
Is the Drainage system clean and disinfected periodically?
Yes
No
N/A
17
Does the Manufacturing area such as Filling, Punching of Tablets segregated from the packaging lines to avoid the cross-contamination?
Yes
No
N/A
18
Is the Primary Packaging areas separate from the Secondary Packaging areas, in the production area, to avoid mix-ups?
Yes
No
N/A
19
Do the Lights proper in production areas, especially in the region where the visual checks(checking the ampoules for particles against the white/black background) need to perform?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
20
Is the locker system available and functional for storage Tools & Equipment?
Yes
No
N/A
21
Are all the Service Lines painted to indicate the Contents & Flow?
Yes
No
N/A
22
Are all Balancing and Measuring equipment calibrated on periodically?
Yes
No
N/A
23
Are all the records of Calibration documented?
Yes
No
N/A
24
Are the required equipment for Balancing, Measuring, Washing, and Cleaning available and functional?
Yes
<10% not ok
>=10% not ok
No
N/A
25
Are the Defective Equipment segregated and informed the authorized personnel for servicing/discarding & procuring?
Yes
<10% not ok
>=10% not ok
No
N/A
26
Does the Production area has an adequate number of Staff?
Yes
No
N/A
27
Does the Production Area under proper supervision?
Yes
No
N/A
28
Are all the staff of the Production area got the required and updated Training?
Yes
<10% not ok
>=10% not ok
No
N/A
29
Are all the Personnel available in the Production area wearing protective clothing and equipment(Uniforms, Gloves, Mask, etc.)?
Yes
No
N/A