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CHAPTER 01
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|
REF:
WHO
32
|
ADMINISTRATION
AND GENERAL INFORMATION
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|
1
|
What
is the company's name?
________________________________________________
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2
|
What
is the company's legal address?
___________________________________________________________
___________________________________________________________
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3
|
What
is the manufacturing site’s address?
___________________________________________________________
___________________________________________________________
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4
|
Does
the company have authorization, according to the regulations
of each country, at other address(es) (warehouses, quality
control laboratory, etc.) which are under the company’s
responsibility?
If "YES", indicate which companies and
provide their addresses.
___________________________________________________________
___________________________________________________________
___________________________________________________________
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5
|
Is
there evidence of registration of the qualified person
responsible by the Regulatory Authority?
___________________________________________________________
___________________________________________________________
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6
|
Is
the qualified person responsible, according to company's
organization chart, present at the time of the inspection?
YES
PROVIDE
INFORMATION REGARDING THIS PERSON (WHO RECEIVES THE
INSPECTION)
-------------------------------------------------------------------------------------------------------
NO
|
|
REF:
WHO
32
|
ADMINISTRATION
AND GENERAL INFORMATION
|
|
7
|
Is
there evidence of a license to operate issued by the
Regulatory Authority?
Indicate
all authorized activities
___________________________________________________________
___________________________________________________________
___________________________________________________________
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|
8
|
Does
the company develop exclusively those production and quality
control activities properly authorized by the Regulatory
Authority?
YES
NO
|
|
9
|
Does
the company manufacture dietary supplements?
YES
NO
|
|
10
|
Does
the company manufacture cosmetic products?
YES
NO
|
|
11
|
Does
the company manufacture veterinary products?
YES
NO
|
|
12
|
Does
the company manufacture reagents for “in vitro”
diagnostic use?
YES
NO
|
|
13
|
Does
the company manufacture reagents for “in vivo”
diagnostic use?
YES
NO
|
|
14
|
Does
the company manufacture other products not indicated above?
YES
If
“YES” indicate below
-----------------------------------------------------------------------------------------------------
NO
|
|
REF:
WHO
32
|
ADMINISTRATION
AND GENERAL INFORMATION
|
|
15
|
Does
the company manufacture products with beta-lactam active
ingredients (penicillins / cephalosporins)?
YES
If
"YES", indicate in which pharmaceutical dosage
form
-----------------------------------------------------------------------------------------------
NO
|
|
16
|
Does
the company manufacture products with cytostatic / cytotoxic
active ingredients?
YES
If "YES", indicate in which pharmaceutical
dosage form
---------------------------------------------------------------------------------------------------------
NO
|
|
17
|
Does
the company manufacture products with hormone active
ingredients?
YES
If "YES", indicate in which pharmaceutical
dosage form
-----------------------------------------------------------------------------------------------------------------------
NO
|
|
17.1
|
Does
the company manufacture products with corticosteroids active
ingredients?
YES
If "YES", indicate in which pharmaceutical
dosage form
----------------------------------------------------------------------------------------
NO
|
|
18
|
Does
the company manufacture products with active ingredients
from biological origin?
YES
If "YES", indicate in which pharmaceutical
dosage form
-----------------------------------------------------------------
NO
|
|
REF:
WHO
32
|
ADMINISTRATION
AND GENERAL INFORMATION
|
|
19
|
Does
the company manufacture products with active ingredients
from biotechnological origin?
YES
If "YES", indicate in which pharmaceutical
dosage form
----------------------------------------------------------------
NO
|
|
20
|
Is
there a list available of current licensed products? Attach
the list
YES
NO
|
|
21
|
Is
there a list available of marketed products? Attach the list
YES
NO
|
|
21.1
|
Do
all marketed products and its pharmaceutical presentations
have current (valid) license?
YES
NO
|
|
22
|
Are
the updated building schematics approved by the Regulatory
Authority shown, if required?
YES
NO
|
|
23
Section
8.
|
Does
the company have contract production activities?
YES
NO
|
|
24
Section
8
|
Is
there documentation certifying registration /authorization
of the third party contracted by the Regulatory Authority?
YES
NO
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