Supplier Quality Questionnaire

239079731.doc Page 1 of 12
A. General Information on Company, Product and
Quality Management
1. Company Information
1.
1
Company Address Information
Name of company:
Address:
Postcode:
Country:
Telephone number:
Fax number:
eb address:
1.
2
Is the address listed aboe the only site
for production!
!es No
If "#, please proide
details belo$%
Name of company"s#:
Address:

Postcode:
Telephone number:
Fax number:
1.
&
Is your company a subsidiary! !es No
If 'es, please proide
details belo$%
Name of company:
Address:
Postcode:
Telephone number:
Fax number:
Supplier Quality Questionnaire
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1.
(
Contact Information )Please proide details of an aailable contact*
Name:
Position:
Telephone number:
Fax number:
$mail address:
1.
+
,ite Personnel Information
1.%.
1
Approximate total number of employees at facility of
interest:

1.%.
&
Approximate number of employees in the 'uality (nit
"'uallity Assurance)'uality Control#

1.%.
*
Approximate number of employees in
Production)+perations (nit

1.%.
,
If a-ailable. please enclose a copy of your
+r/anisational chart indicatin/ 0ey personnel.
$nclosed
1ef:

N)A
1.%.
%
If a-ailable. could you please supply copies of any
sales information for the products listed on the front of
this form2
$nclosed
1ef:

N)A
1.%.
3
4oes your factory operate in a shift system2 !es No
5o6 many2
5o6 many days a 6ee02
1.
-
Company structure
1.3.
1
hat is the le/al o6nership structure of your
company2

1.3.
&
Please /i-e a brief structure7dia/ram 1ef:
1.3.
*
4o you expect a chan/e of the le/al status and)or o6nership of your
company in the near future2
!es No
Supplier Quality Questionnaire
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1.3.
,
4o you ha-e an annual report a-ailable2 !es No
If yes. please enclose the annual report 1ef:
&. Product Information
&.*
+ri/in of the main in/redients Comments
&.*.
1
8ynthetic !es
No N)A
&.*.
&
Fermentation !es
No N)A
&.*.
*
9e/etable !es
No N)A
&.*.
,
:ineral !es
No N)A
&.*.
%
Animal "if !$8. please complete section ; as
6ell#
!es
No N)A
&.*.
%
;o-ine "or by7products# !es
No N)A
&.*.
%
Porcine "or by7products# !es
No N)A
&.*.
%
Poultry "or by7products# !es
No N)A
&.*.
%
Fish "or by7products# !es
No N)A
&.*.
%
5uman "or by7products# !es
No N)A
&.,
+ri/in of the carrier components and)or any material used in the
manufacture
Comments
&.,.
1
8ynthetic !es
No N)A
&.,.
&
Fermentation !es No N)A
&.,.
*
9e/etable !es No N)A
&.,.
,
:ineral !es No N)A
&.,.
%
Animal "if !$8. please complete section ; !es No N)A
Supplier Quality Questionnaire
239079731.doc Page 4 of 12
as 6ell#
&.,.
%
;o-ine "or by7products# !es No N)A
&.,.
%
Porcine "or by7products# !es No N)A
&.,.
%
Poultry "or by7products# !es No N)A
&.,.
%
Fish "or by7products# !es No N)A
&.,.
%
5uman "or by7products# !es No N)A
&.%
Additi-es "if applicable# Comments
&.%.
1
Additi-e $ Numbers !es
No N)A
&.%.
1
+ther additi-es than colours and
s6eeteners "4ir. <%)&)$C= and subse>uent
amendments.#
!es No N)A
&.%.
1
Purity criteria "4ir. <3)??)$C= and
subse>uent amendments.#
!es No N)A
&.%.
1
+ther rele-ant purity criteria applicable !es No N)A
&.3
+ther products supplied to us:

*. 'uality 8tandards and Certi@cations
*.1 4o you hold certi@cation"s# a/ainst any reco/niAed
>uality standards by a accredited third party body e./.
I8+ <BB1. 1,BB1 or &&BBB2 If yes. please pro-ide a
copy of certi@cate"s#.
!es 1ef: No N)A
*.& 4o you hold accreditation. certi@cation or re/istration
by any re/ulatory a/ency or body2 If yes. please
pro-ide a copy of documentation
!es 1ef: No N)A
*.* Are any aspects of the process ) ser-ice pro-ided
subcontracted2
!es No N)A
Supplier Quality Questionnaire
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*.*.
1
If so. please pro-ide
detail:

*.*.
&
Are there 'uality ) Technical A/reements held 6ith
subcontractors2
!es No N)A
Supplier Quality Questionnaire
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,. 'uality :ana/ement 4ocumentation
4o you ha-e procedures that document ho6 you perform the follo6in/ acti-ities:
If C!$8D please pro-ide the document reference number ) identi@cation.
In case you are certi@ed to6ards I8+<BB1. only ,.1.&. ,.1.?. ,.1.11. ,.&.1. ,.&.&. ,.,.1. ,.,., and
,.%.& are mandatory.
(.1 Q.A/I0' ,',01M Comment
,.1.
1
'uality Policy ) :anual !es No N)A
,.1.
&
$>uipment E Instrument 9alidation )
'uali@cation Pro/ram
!es No N)A
,.1.
*
Internal Audit ) 8elf7Inspection Pro/ram !es No N)A
,.1.
,
8upplier $-aluation ) 'uali@cation Pro/ram !es No N)A
,.1.
%
4oes your company operate a supplier7
auditin/ system2
!es No N)A
,.1.
3
Trainin/ Pro/ram !es No N)A
,.1.
?
Chan/e Control !es No N)A
,.1.
F
4e-iation ) In-esti/ation 1eportin/ !es No N)A
,.1.
<
Non7Conformance 1eportin/ !es No N)A
,.1.
1B
4ocumentation Control !es No N)A
,.1.
11
4o you ha-e a recall system)procedure in
place2
!es No N)A
(.2 P2#3.C0I#" 4 #P12A0I#", ,',01M
,.&.
1
$n-ironmental :onitorin/ Pro/ram !es No N)A
,.&.
&
5ouse0eepin/ Pro/ram !es No N)A
,.&.
*
Go6nin/ ) $ntry E $xit Procedure !es No N)A
,.&.
,
A-ailability of :aster Production Instructions
and ;atch production 1ecords
!es No N)A
,.&.
%
A-ailability of $>uipment Cleanin/
Procedures. Cleanin/ 1ecords and Cleanin/
9eri@cation
!es No N)A
(.& PAC5AGI"G 4 /A61//I"G ,',01M
Supplier Quality Questionnaire
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,.*.
1
Habellin/ of Intermediate ) Final Products !es No N)A
,.*.
&
8tora/e of Intermediate ) Final Products !es No N)A
,.*.
*
Product ) 8ample 8hippin/ 9alidation
Pro/ram
!es No N)A
(.( 7ACI/I0I1, A"3 1Q.IPM1"0 ,',01M
,.,.
1
Pest Control Pro/ram !es No N)A
,.,.
&
Pre-enti-e :aintenance Pro/ram !es No N)A
,.,.
*
Calibration Pro/ram !es No N)A
,.,.
,
Facility Cleanin/ ) 8anitiAation !es No N)A
Supplier Quality Questionnaire
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(.+ /A6#2A0#2' C#"02#/ ,',01M Comment
,.%.
1
:ethod 'uali@cation for all assays used in
Testin/ of 8amples
!es No N)A
,.%.
&
Testin/ 1ea/ents and 8tandards Controls
Policy ) Procedure
!es No N)A
,.%.
*
8ample 1etention Pro/ram !es No N)A
,.%.
,
+ut of 8peci@cation "++8# ) 1etest
Procedures
!es No N)A
,.%.
%
A-ailability of Analytical 1a6 4ata
4ocumentation
!es No N)A
(.- MA012IA/, C#"02#/ ,',01M
,.3.
1
:aterials :o-ement into the Facility !es No N)A
,.3.
&
In-entory :ana/ement 8ystem !es No N)A
,.3.
*
arehouse 8ystem and 8tora/e !es No N)A
,.3.
,
Inspection and Testin/ of Incomin/ :aterials !es No N)A
(.8 #0912
,.?.
1
Contract 1e-ie6 !es No N)A
,.?.
&
8upply Chain 1e>uirements !es No N)A
,.?.
*
Product Identi@cation ) Traceability !es No N)A
5. 1e/ulatory Compliance and 5istory
%.1
5as the company been subIect to periodic audit by
competent authorities e./. :51A. F4A. I8+ inspection body
etc2
!es No N)A
%.1.
1
If C!$8D please pro-ide details belo6 for the past & years and attach supportin/ documents
"e./. I8+ certi@cate. G:P certi@cate. $I1 co-er letter#
Authority Date Result




Supplier Quality Questionnaire
239079731.doc Page 9 of 12
%.&
2egulatory Compliance
"If !$8 is applicable. please specify the le/islation the material is compliant
6ith#
Comment
1emar0:
If !$8. please specify the le/islation you are
compliant to
%.&.
1
:ycotoxin "1e/ulation 1FF1)&BB3)$C and
subse>uent amendments#
!es No N)A
%.&.
&
4ioxin "1e/ulation 1FF1)&BB3)$C and
subse>uent amendments#
!es No N)A
%.&.
*
Ionisation !es No N)A
%.&.
,
Pesticide 1esidues !es No N)A
%.&.
%
5ea-y :etals 8peci@ed !es No N)A
%.&.
3
Polycyclic Aromatic 5ydrocarbons "PA5# !es No N)A
%.&.
?
Polychlorinated ;iphenyls "PC;s# !es No N)A
%.&.
F
Nitrate !es No N)A
%.&.
<
;8$ ) T8$ !es No N)A
%.&.
1B
Product 4ata 8heet !es No N)A
%.&.
11
8afety 4ata 8heet !es No N)A
3. Industry 5istory
3.1
4o you supply to any other customer in the Pharmaceutical )
5ealth care industry2
!es No N)A
3.1.
1
If C!$8D. Please specify the approximate J of your business
that this relates to:

3.&
5a-e you been audited by any Pharmaceutical ) 5ealth care
companies 6ithin the last t6o years2
!es No N)A
Supplier Quality Questionnaire
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8. Comments

Supplier Quality Questionnaire

239079731.doc Page 11 of 12
:. 2eferences ; Appendices
Please, list all references and enclosures that you ma<e to this =uestionnaire
and specify the reference number gien to each document. .se one list for all
sections of the document and e>tend it if needed.
2ef ? 3escription4"ame
Supplier Quality Questionnaire
239079731.doc Page 12 of 12
@. ,ections completed
Please, tic< the bo>es for the sections you hae completed.
,ections A A General Company Information and Quality Management Questionnaire
,ections 6 A 6,146,1 2is< Analysis ,urey
,ections C A GM# A Begetable #rigin
,ections 3 A Allergen
,ections 1 A 1>tended Quality Questionnaire for Critical Material
,ections 7 A Pac<aging Material
Completion 8i/natures
Con@rmation that enclosed information is correct and rele-ant to the product"s# in
scope.
!ou 6ill inform us in case of any chan/es to the product status
8ite +perations Head 1epresentati-e:
Name "Print #:

Position:

8i/nature:
4ate:
5ead of 'uality Assurance or representati-eK person 6ho completed the >uestionnaire:
Name "Print#:

Position:

8i/nature:
4ate: