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Supplier Questionnaire
Supplier Questionnaire
xxxxxxxxx
SUPPLIER QUESTIONNAIRE
SUPPLIER QUESTIONNAIRE
Company Name:
Version xxxxxx
Ref.No:
Please complete this questionnaire, by hand and within 30 days return to (Name of
contact person).
Name and title of person returning
the questionnaire
Date
Are you:
Producer
Distributor
Contract
manufacturer
Contract Lab
1 General Information
1.1 Primary contacts
1.1.1 Name of company
1.1.2 Adress of company
1.1.3 Telephone Number
1.1.4 Fax Number
1.1.5 E-Mail
1.1.6 Web site
1.1.7 Name of Chief Executive
1.1.8 Name of Sales Respresative
1.1.9 Name of QP/Members of the
Quality Unit
1.1.10 Name of person responsible
for Quality Management
1.1.11 Name of person responsible
for Regulatory Affairs
1.1.12 Name of person responsible
for Customer Service
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SUPPLIER QUESTIONNAIRE
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1 10 M
10 100 M
100 1000 M
1.2.6 Subsiduaries
YES
NO
YES
NO
YES
NO
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>1000 M
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SUPPLIER QUESTIONNAIRE
1.3.5 If any other companies are subcontracted in any of the activities related to this product
please give their name and address.
Activity
YES
NO
2 Quality System
2.1 Quality Policy
2.1.1 Is your company registred at
the responsible GMP authority
YES
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NO
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SUPPLIER QUESTIONNAIRE
YES
NO
YES
NO
YES
NO
YES
NO
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2.3 Purchasing
2.3.1 How are you suppliers
approved, and by whom?
YES
NO
YES
NO
YES
NO
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contract transport
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SUPPLIER QUESTIONNAIRE
YES
NO
YES
NO
Yes - comuterised
No
YES - manual
Yes - comuterised
No
YES
NO
YES
NO
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YES
NO
YES
NO
YES
NO
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YES
NO
YES
NO
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YES
NO
YES
NO
YES
NO
2.9 Training
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SUPPLIER QUESTIONNAIRE
YES
NO
YES
NO
YES
NO
Is the computer
system validated?
2.11.1 For
documentation
Yes
No
Yes
No
2.11.2 Warehousing
Yes
No
Yes
No
Yes
No
2.11.3 Laboratory
(LIMS)
Yes
No
Yes
No
Yes
No
2.11.4 Manufacturing
process control
Yes
No
Yes
No
Yes
No
2.11.5 ERP
(Enterprise Resource
planning)
Yes
No
Yes
No
Yes
No
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SUPPLIER QUESTIONNAIRE
YES
NO
YES
NO
YES
NO
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YES
NO
Comment:
YES
NO
Operation
YES
NO
Mainteneance
YES
NO
Calibration
YES
NO
Cleaning
YES
NO
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YES
NO
YES
NO
EP
USP
YES
NO
YES
NO
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OTHER
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SUPPLIER QUESTIONNAIRE
Certificate of Analysis
certificate of conformance
other
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
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YES
NO
YES
NO
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SUPPLIER QUESTIONNAIRE
No significant
deficiencies
Minor
deficiencies
Date
17 of 17
Mayor
deficiencies
Deficiencies
not
acceptable
N.A