NR.
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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
Name of substance/s supplied
Annexes:
Questonnaire APIs/Excipients/Packaging/QC-Labs/Toll Manufacturer etc.
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
1.1.13 Company organigram
1.1.14 Number of employees in
total
1.1.15 Number of employees in
QC/QA/QM
1.1.16 Number of employees in
production
1.1.17 Number of employees in
Administration
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SUPPLIER QUESTIONNAIRE
1.2 Company Profile
1.2.1 If the company is part of a
larger group, give the name and
address of head office
1.2.2 Legal Status of the Company
1.2.3 Annual Turnover
1 10 M
10 100 M
100 1000 M
1.2.4 Founding year
1.2.5 Business activities
1.2.6 Subsiduaries
1.2.7 Area of production sites
1.2.8 Location of production sites
1.3 General commercial and Customer Service
1.3.1 Would you allow us or a third
party to inspect your facilities?
1.3.2 Has any other company or
third party audited you? If yes, how
many?
1.3.3 Would you provide us a copy
of a third party audit report?
YES
NO
YES
NO
YES
NO
1.3.4 Please note down any major
customers particularly
pharmaceutical customers, with
whom you work (optionel)
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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
Name and Address
1.4 Site Information
1.4.1 Would you supply a site
master file?
YES
NO
2 Quality System
2.1 Quality Policy
2.1.1 Is your company registred at
the responsible GMP authority
Please attach copie of the registration letter
2.1.2 Is your company under
surveillance by the responsible
GMP authority
Please state name and adresss of the authority
2.1.3 Does the company have
current ISO / HACCP / IFS / GMP
or any other relevant certification?
Please attach copie
2.1.4 Does the certification apply to
the whole operation?
YES
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NO
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SUPPLIER QUESTIONNAIRE
2.1.5 If NO, please explain the
scope of the certification
2.1.6 If the company is not certified,
do you have plans to get certified?
YES
NO
YES
NO
YES
NO
YES
NO
2.1.7 If YES, when is your first
inspection expected?
2.1.8 Does your company have a
Quality Manual? If so, attach table
of contens
2.1.9 Has any Authority or
Regulatory body inspected your
facilities? Please state Name and
Country:
2.2 Quality Improvement
2.2.1 Do you carry out selfinspections of your facilities and
systems?
2.2.2 How often?
2.2.3 How do you monitor
effectiveness and closure of
corrective actions?
2.2.4 How is the senior
management kept aware of the
quality improvement program?
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2.3 Purchasing
2.3.1 How are you suppliers
approved, and by whom?
2.3.2 Do you maintain a list of
certified, and acceptable suppliers,
categorised accordingly?
YES
NO
2.3.3 Do your systems allow you to
use products of unapproved
suppliers?
YES
NO
2.3.4 Do you purchase against
agreed specifications only?
2.4 Materials Management Warehousing & Dispatching
2.4.1 What type of pest control
system do you use?
2.4.2 How often do you inspect for
pests?
2.4.3 Are storage conditions
monitored/controlled in warehouse?
YES
NO
If Yes please state the ranges
2.4.4 How do you dispatch finished
goods?
own transport
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contract transport
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SUPPLIER QUESTIONNAIRE
2.4.5 Do you consider the rules of
Good Distribution and
Transportation Practice?
YES
NO
If YES please SPECIFY
2.5 Materials Management Labelling
2.5.1 What checks are carried out on
incoming materials?
2.5.2 Do you apply in house identily
labels on incoming goods?
YES
NO
2.5.3 If not how do you identify
materials?
2.5.4 Do you operate First in First
out ?
YES - manual
Yes - comuterised
No
YES - manual
Yes - comuterised
No
2.5.5 Do you operate a material
location system?
2.5.6 If the system is computerised,
is it validated?
YES
NO
2.5.7 Do you store more than one
product per location?
YES
NO
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2.5.8 Do you operate a quarantine
system for incoming raw materials?
YES
NO
YES
NO
YES
NO
2.5.9 How do you prevent quarantine
material from being used?
2.5.10 Do you have a status labelling
system?
2.5.11 How is your batch numbering
system build up?
2.5.12 What system do you use to
maintain he traceability of materials?
2.5.13 How are rejected materials
separated?
2.6 Document Control
2.6.1 Is there a formal system for
reviewing and updating SOPs,
specifications, manufacturing
instructions?
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2.6.2 How do you ensure that
obsolete/ superseded documents
according to 2.7.1 are not used?
2.6.3 How long, how and where are
batch documents archived?
2.7 Change Control
2.7.1 Is a change control system in
place?
YES
NO
YES
NO
2.7.2 What scopes are subjected to
Change Control?
2.7.3 By whom are risks of changes
assessed, classified and authorized?
2.7.4 When and how do you inform
your customers about changes?
2.7.5 Are you willing to sign a change
control agreement
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2.8 Deviation Management
2.8.1 Is a deviation management
system in place?
YES
NO
2.9.1 Is a GMP compliant training
system in place?
YES
NO
2.9.2 Is training documented and
verified by testing?
YES
NO
2.8.2 What scopes are subjected to
Deviation Management?
2.8.3 By whom are risks of deviations
assessed? Who determines
correctives and preventive actions?
2.8.4 When and how do you inform
your customers about deviations?
2.9 Training
2.9.3 At what interval do you retrain
staff?
2.9.4 Which training other than GMP
is carried out?
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2.10 Complaints and Recall
2.10.1 Is there a formal complaint
procedure?
YES
NO
2.10.2 Do you report findings to
customers?
YES
NO
YES
NO
2.10.3 Who is responsible for this
procedure?
2.10.4 In what time period would you
normally reply to a formal complaint?
2.10.5 Is there a recall policy?
2.10.6 Who is responsible for recalls?
2.10.6 How do you ensure
traceability of all products an case of
a recall?
2.11 Computer Systems
Are IT Systems
used?
Is the computer
system validated?
2.11.1 For
documentation
Yes
No
Yes
No
Does data storage
comply with US
requirements (21
CFR part 11)
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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3 Quality Testing and Release of Materials and Products
3.1 Quality Control laboratory facilities and systems
3.1.1 Do you have on-site laboratory
or QC facilities?
YES
NO
YES
NO
YES
NO
3.1.2 If yes, what kind of testing do
you apply?
3.1.3 Is your QC department
independent from production?
(please provide organigram)
3.1.4 Do use contract laboratories?
3.1.5 If Yes, which labs and which
tests?
3.1.6 Are the labs accredited/
certified? According to which
standard?
3.1.7 Are the labs qualified and
audited by your company or a third
party?
3.1.8 Are written quality contracts in
place?
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3.1.9 Are all laboratory instruments
and measuring devices & calibrated?
YES
NO
Comment:
3.1.10 Do you maintain a calibration
schedule?
3.1.11 Are there written instructions
for the laboratory equipment?
YES
NO
Operation
YES
NO
Mainteneance
YES
NO
Calibration
YES
NO
Cleaning
YES
NO
3.1.12 Do you have a sampling plan
for the material delivered to us?
Please give a short description.
3.1.13 Who conducts sampling and
where?
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3.2 Quality Control laboratory testing
3.2.1 Do you have specifications for
the raw materials, intermediates and
finished products?
3.2.2 Do you use reference
standards?
YES
NO
YES
NO
If Yes, which ones:
EP
USP
3.2.3 Is a written procedure for
handling of reference standards,
chemicals and reagents in place?
3.2.4 What testing is carried out on
the final product?
3.2.5 Are there written instructions for
the tests?
YES
NO
YES
NO
3.2.6 Are the tests validated or do
you use verified compendial
methods?
3.2.7 How do you deal with out of
spec test results?
3.2.8 Do you retain samples from raw
materials and finished products?
3.2.9 If YES, please indicate amount,
storage time and conditions
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OTHER
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SUPPLIER QUESTIONNAIRE
3.2.10 Do you provide certification of
each batch/ lot of product?
Certificate of Analysis
certificate of conformance
other
3.2.11 Can provide certification to
include a specific customer
requirement?
YES
NO
3.2.12 Do you execute storage
stability testing acc. to ICH and can
you provide corresponding stability?
YES
NO
3.3.1 Are there written procedures for
the dispositioning (approval or
rejection ) of incoming materials?
YES
NO
3.3.2 Are there written procedures for
the dispositioning (approval or
rejection ) of finished products?
YES
NO
3.3.3 Does a qualified person/ quality
unit review the batch records before
the batch is released and certified?
YES
NO
3.2.13 If YES, please indicate the
shelf live/ retest date and
corresponding storage conditions.
3.3 Batch Release
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3.4 Hygiene system
3.4.1 Are you operating a functional
hygiene system? If YES please
specify?
YES
NO
YES
NO
3.4.2 What areas are included by this
system?
3.4.3 Please describe the fey
elements and scopes of your hygiene
plan.
3.4.4 Do you operate a hygiene
monitoring system? If YES please
specify.
3.4.5 How do you evaluate your
hygiene monitoring system? Please
specify.
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3.5 Final evaluation by submittor:
No significant
deficiencies
Minor
deficiencies
2.1 Quality Policy
2.2 Quality
Improvement
2.3 Purchasing
2.4 Materials
Management
Warehousing &
Dispatching
2.5 Materials
Management Labelling
2.6 Document Control
2.7 Change Control
2.8 Deviation
Management
2.9 Training
2.10 Complaints and
Recall
2.11 Computer
Systems
3.1 Quality Control
laboratory facilities
and systems
3.2 Quality Control
laboratory testing
3.3 Batch Release
3.4 Hygiene system
Name and title of person
evaluating the
questionnaire
Date
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Mayor
deficiencies
Deficiencies
not
acceptable
N.A
