Supplier Questionnare - Section E Quality Q. - Modified
Supplier Questionnare - Section E Quality Q. - Modified
Supplier Questionnare - Section E Quality Q. - Modified
318270110.doc
Page
of
Product Code
1. General Information
1.1.
Yes
No
1.2
Yes
No
1.3.
1.4
1.5.
1.6
Yes
No
Yes
No
Yes
No
Technical products?
Yes
No
Packaging material?
Yes
No
Others?
Yes
No
Please, specify:
1.7
Ref:
20
Page
of
20
Yes
No
N/A
2.2
Yes
No
N/A
2.3
Yes
No
N/A
2.4
Is your personnel aware that the products supplied are used for
the manufacturing of active pharmaceutical ingredients?
Yes
No
N/A
2.5
2.5.
1
Yes
No
N/A
2.5.
2
Yes
No
N/A
2.5.
3
Yes
No
N/A
2.5.
4
Yes
No
N/A
2.5.
5
Yes
No
N/A
2.5.
6
Yes
No
N/A
2.5.
7
Yes
No
N/A
2.5.
8
Yes
No
N/A
2.6
2.6.
1
Product integrity?
Yes
No
N/A
2.6.
2
Hygiene?
Yes
No
N/A
2.6.
3
Cleanliness?
Yes
No
N/A
2.6.
4
Other?
Yes
No
N/A
Please specify:
Page
of
20
3.2
designed
adapted
3.2.1
Yes
No
N/A
3.2.2
Manufacturing?
Yes
No
N/A
3.2.3
Yes
No
N/A
3.2.4
Yes
No
N/A
3.2.5
Yes
No
N/A
3.2.6
Yes
No
N/A
3.3
3.3.1
Chemical contamination?
Yes
No
N/A
3.3.2
Physical contamination?
Yes
No
N/A
3.3.3
Microbial contamination?
Yes
No
N/A
3.4
3.4.1
Yes
No
N/A
3.4.2
Yes
No
N/A
3.4.3
Yes
No
N/A
3.4.4
Yes
No
N/A
3.4.5
Yes
No
N/A
3.5
Yes
No
N/A
3.5.1
Yes
No
N/A
3.6
Yes
No
N/A
3.7
Yes
No
N/A
3.8
Yes
No
N/A
3.9
Yes
No
N/A
3.10
Yes
No
N/A
Page
of
4.1.1
4.2
multi
single
Yes
No
N/A
4.3
Yes
No
N/A
4.4
Yes
No
N/A
4.5
Yes
No
N/A
4.6
Yes
No
N/A
4.7
Yes
No
N/A
4.8
Yes
No
N/A
4.9
Yes
No
N/A
4.10
Yes
No
N/A
4.11
Yes
No
N/A
4.11.1
If yes,
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
4.12
4.12.1
Instrument Calibration?
Yes
No
N/A
4.12.2
Yes
No
N/A
20
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20
Yes
No
5.1.1
Yes
No
5.1.1.
1
5.2
5.3
5.4
5.5
5.6
If, for capacity reasons, you combine material coming from more than one particular piece
or part of process equipment into one lot/batch:
5.6.1
Yes
No
N/A
5.6.2
Yes
No
N/A
5.7
Yes
No
N/A
5.8
Yes
No
N/A
5.9
Yes
No
N/A
5.9.1
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
5.9.2
Yes
No
N/A
5.9.3
Yes
No
N/A
5.10
No
N/A
Manufacturing?
Page
of
Packaging?
Yes
No
N/A
Storage?
Yes
No
N/A
20
Page
of
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
5.14
Yes
No
N/A
5.15
Yes
No
N/A
5.16
Yes
No
N/A
5.17
Yes
No
N/A
5.18
Yes
No
N/A
5.19
Yes
No
N/A
5.20
Yes
No
N/A
5.11
5.12
5.12.1
5.13
5.20.1
5.21
Yes
No
N/A
5.22
Yes
No
N/A
5.23
Yes
No
N/A
5.24
Yes
No
N/A
5.25
Yes
No
N/A
5.26
Yes
No
N/A
5.27
Yes
No
N/A
20
Page
5.28
Yes
5.29
5.30
Yes
5.30.1
5.31
5.32
No
5.32.1
Raw materials?
5.32.2
Semi-finished product?
5.32.3
Finished product?
of
N/A
Years
No
main
Yes
N/A
hol
No
N/A
20
Page
of
6. Materials Control
6.1
Yes
No
N/A
6.2
Yes
No
N/A
6.3
Yes
No
N/A
6.4
6.5
Yes
No
N/A
6.6
Yes
No
N/A
6.7
Yes
No
N/A
6.8
Yes
No
N/A
6.9
Yes
No
N/A
6.10
Do you maintain information records for raw materials which include the following:
Yes
No
N/A
Yes
No
N/A
Date of Receipt?
Yes
No
N/A
Quantity?
Yes
No
N/A
Suppliers name?
Yes
No
N/A
Shelf Life?
Yes
No
N/A
Test Results?
Yes
No
N/A
Specification?
Yes
No
N/A
Accepted/Rejected?
Yes
No
N/A
Retained Sample?
Yes
No
N/A
6.11
6.12
Yes
No
N/A
6.13
Yes
No
N/A
6.14
Yes
No
N/A
20
Page
10
of
20
Page
11
of
7. Quality Control
7.1
Yes
No
N/A
7.2
7.3
Yes
No
N/A
7.4
Yes
No
N/A
Identity of samples?
Yes
No
N/A
Results of testing?
Yes
No
N/A
Yes
No
N/A
7.5
Yes
No
N/A
7.6
Yes
No
N/A
7.7
Yes
No
N/A
7.8
Yes
No
N/A
7.9
Yes
No
N/A
7.10
Yes
No
N/A
7.11
Yes
No
N/A
7.12
Yes
No
N/A
7.13
Yes
No
N/A
7.14
7.15
Starting materials?
Yes
No
N/A
In-process control?
Yes
No
N/A
Yes
No
N/A
Finished products?
Yes
No
N/A
Microbiological control?
Yes
No
N/A
20
Page
12
of
20
Page
No
13
of
7.16
Yes
N/A
7.16.1
7.17
Yes
No
N/A
7.18
Yes
No
N/A
7.18.1
If yes:
7.18.1
.1
Yes
No
N/A
Years
7.18.1
.2
Yes
No
N/A
7.18.1
.3
Yes
No
N/A
7.19
Yes
No
N/A
7.19.1
If yes:
7.19.1
.1
Yes
No
N/A
7.19.1
.2
Yes
No
N/A
7.19.1
.3
Yes
No
N/A
7.19.1
.4
Yes
No
N/A
7.20
Yes
No
N/A
7.21
7.21.1
7.21.2
7.22
Yes
No
N/A
7.23
Yes
No
N/A
7.24
7.25
Yes
Years
No
N/A
20
Page
14
of
8. Quality Assurance
8.1
8.2
Yes
No
N/A
No
N/A
8.3
8.4
8.5
8.6
Yes
No
N/A
8.7
Yes
No
N/A
8.8
Yes
No
N/A
8.8.1
Yes
No
N/A
8.9
Yes
No
N/A
8.10
Yes
No
N/A
8.11
Yes
No
N/A
8.11.1
8.11.2
Yes
No
N/A
8.11.3
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
8.11.4
8.12
8.13
Yes
20
Page
15
of
8.13.1
Yes
No
N/A
8.14
Yes
No
N/A
20
Page
16
of
Yes
No
N/A
9.2
Yes
No
N/A
9.3
Yes
No
N/A
9.4
Yes
No
N/A
9.5
Yes
No
N/A
9.6
Contractor
N/A
9.7
Yes
No
N/A
9.7.
1
Yes
No
N/A
9.8
Yes
No
N/A
9.9
Yes
No
N/A
9.10
Yes
No
N/A
Packaging operation?
Yes
No
N/A
Yes
No
N/A
9.11
Yes
No
N/A
9.12
Yes
No
N/A
9.13
Yes
No
N/A
9.14
Supplier- Owned
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
20
Page
17
of
9.15
Yes
No
N/A
9.15.1
Yes
No
N/A
9.16
Yes
No
N/A
9.16.1
If yes:
Do you have a SQAS assessment report?
Yes
No
N/A
----
9.17
Yes
No
N/A
9.18
Yes
No
N/A
9.18.1
If yes:
What is the name of this company?
9.19
Yes
No
N/A
9.20
Yes
No
N/A
9.21
Yes
No
N/A
9.22
9.23
Yes
No
N/A
9.23.1
9.24
Yes
No
N/A
9.24.1
----
9.25
Yes
No
N/A
9.26
Yes
No
N/A
9.27
Yes
No
N/A
9.27.1
Yes
No
N/A
9.27.2
Yes
No
N/A
9.27.2
.1
----
9.27.3
Yes
9.27.4
Ref:
9.28
Yes
No
N/A
No
N/A
20
Page
18
of
9.29
Yes
No
N/A
9.29.1
Yes
No
N/A
9.29.2
Yes
No
N/A
9.29.3
Yes
No
N/A
9.29.4
Yes
No
N/A
20
Page
19
of
10.1.1
Yes
No
Yes
No
Yes
No
10.2
Yes
No
10.3
10.4
Have you identified all relevant SHE aspects of your activities and all
relevant legal requirements you have to comply with?
Yes
No
10.5
Yes
No
10.6
Does your site comply with all licenses under relevant laws (Nuisance
Act, Environmental Protection Act, Integrated Pollution Prevention,
Hazardous Waste, etc.)?
Yes
No
10.7
emissions to air
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
nuisance by noise/odour
Yes
No
occupational safety
Yes
No
10.8
Yes
No
10.9
Yes
No
10.9.1
Please specify
10.10
Yes
No
10.11
Yes
No
10.12
Yes
No
10.13
Yes
No
Ref:
10.13.
1
20
Page
Yes
20
of
No
20