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1. Appendix 1 : Copy of valid manufacturing authorization

2. Appendix2 :
List
of
dosage
forms
manufactured
the
INN-names
or common name (as available)
pharmaceutical ingredients (API) used
3. Appendix 3 : Copy of valid GMP Certificate

90

-4-11

including
of active

4. Appendix4:
List
of
contract
manufacturers
and
information,
laboratories
including
the addresses and contact
and
flow-charts of
the supply-chains for these outsourced
activities
5. Appendix 5: Organizational charts
6. Appendix 6:
Lay
outs
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production
areas
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material
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personnel flows,
general
flow
charts
of
manufacturing processes of each product type (dosage form)

7. Appendix 7 : Schematic drawings of water systems

8. Appendix
equipment

8:

List

of

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major

production

# $ %

!+!

and

"

laboratory

,-

Site Master File

GUD

1392/09/15

" !

1392/09/15

" !

1394/09/15

#$% "

1394/09/15

#$% "

:T%

&D -5
0

&D -6

1. EXPLANATORY

NOTES
FOR PHARMACEUTICAL
MANUFACTURERS ON
THE
PREPARATION
OF
A SITE
MASTER FILE Pic/S Pe 008-4 ,1-January 2011

.2

IN HOUSE () R7

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# $ %

!+!

"

,-