Professional Documents
Culture Documents
WHOINSP-Inj Check List
WHOINSP-Inj Check List
Page 1 of 32
INSPECTION OF:
Date:
Products manufactured
Location of production
Names of Inspectors:
Affiliation of Inspectors:
_________________
____________________
_________________
____________________
_________________
____________________
_________________
____________________
_________________
____________________
_________________
____________________
Date(s) of inspection:
inspection
From
_____________________
_________________
____________________
_____________________
To
_____________________
_________________
Type: ______________
______________
QA audit report #_______
_____________________
_____________________
_________________
Y{ }
Y{ }
N{ }
N{ }
Page 2 of 32
INSPECTION OF:
Date:
SUMMARY OF SENIOR PERSONNEL, A: (use next of these departmental divisions are not
appropriate, or for other department designations)
ADMINISTRATION
Position Title
Name
_____________________________
_____________________________
_____________________________
_____________________________
_____________________________
_____________________________
PRODUCTION DEPARTMENT
Position Title
Name
Qualifications
_____________________________
________________
__________________
_____________________________
________________
__________________
_____________________________
________________
__________________
_____________________________
________________
__________________
ANIMAL FACILITIES
Position Title
Name
Qualifications
_____________________________
________________
__________________
_____________________________
________________
__________________
ENGINEERING / MAINTENANCE
Position Title
Name
Qualifications
_____________________________
________________
__________________
_____________________________
________________
__________________
Name
Qualifications
_____________________________
________________
__________________
_____________________________
________________
__________________
Name
Qualifications
_____________________________
________________
__________________
_____________________________
________________
__________________
Page 3 of 32
INSPECTION OF:
Date:
Name
___________________
Qualifications
___________________
________________________
___________________
___________________
________________________
___________________
___________________
_____________DEPARTMENT
Position Title
________________________
Name
___________________
Qualifications
___________________
________________________
___________________
___________________
________________________
___________________
___________________
_____________DEPARTMENT
Position Title
________________________
Name
___________________
Qualifications
___________________
________________________
___________________
___________________
________________________
___________________
___________________
_____________DEPARTMENT
Position Title
________________________
Name
___________________
Qualifications
___________________
________________________
___________________
___________________
________________________
___________________
___________________
_____________DEPARTMENT
Position Title
________________________
Name
___________________
Qualifications
___________________
________________________
___________________
___________________
________________________
___________________
___________________
_____________DEPARTMENT
Position Title
________________________
Name
___________________
Qualifications
___________________
________________________
___________________
___________________
________________________
___________________
___________________
Page 4 of 32
INSPECTION OF:
Date:
#
1
Audit Item
Is there an organizational chart?
What departments are identified?
Production departments(s)
__________________
__________________
__________________
__________________
4
5
Filling
{ }
Labeling/Packaging
{ }
Quality control
{ }
Engineering/Maintenance { }
Quality Assurance
{ }
Receiving/Warehousing { }
Shipping/Distribution
{ }
Purchasing
{ }
Animal Procurement/Care { }
Are there job descriptions for key
personnel?
Are they appropriate to the activities of
the department?
Number of engineering staff____
Number sufficient?
Qualifications adequate?
Experience sufficient?
Number of production staff____
Number sufficient?
Qualifications adequate?
Experience sufficient?
Number of quality control staff____
Number sufficient?
Qualifications adequate?
Experience sufficient?
Number of quality assurance staff____
Number sufficient?
Qualifications adequate?
Experience sufficient?
Number of animal care staff____
Number sufficient?
Qualifications adequate?
Experience sufficient?
Is there a clear separation of
responsibility for production from QC?
Is there a clear separation of personnel
from different areas handling animals,
microorganisms, and product?
By
written procedure?
Are the names and qualifications of
those responsible for approving the lot
processing records registered with the
NCA?
Yes
No
NA
Observations (indicate
N.O. if not observed)
Attach org chart, add other
departments or Indicate
departments different from list.
Page 5 of 32
INSPECTION OF:
Date:
Audit Item
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
_____________________________
2
1.0 C: Training
#
Audit Item
Page 6 of 32
INSPECTION OF:
Date:
Audit Item
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 7 of 32
INSPECTION OF:
Date:
2.0 A: General
#
Audit Item
2
a.
b.
c.
d.
e.
f.
g.
h.
3
4
a
b
5
8
a.
b.
c.
d.
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 8 of 32
INSPECTION OF:
Date:
c.
d.
e.
a.
b.
c.
d.
2
a.
b.
c.
d.
e.
f.
g.
h.
i.
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
Page 9 of 32
INSPECTION OF:
Date:
Audit Item
3
a.
b.
Compressed Air
Is the air supply free from oil?
Is the air supply filtered through a
sterilizing grade air filter?
Is humidity controlled?
Clean steam
Is clean steam used for sterilization of
product contact surfaces?
Is the distribution system constructed
of stainless steel treated to prevent
corrosion and sloped for drainage?
Water for injection (WFI) system
Is the design of the WFI system
adequate to supply sufficient water of
compendia (pharmacopoeial)quality?
Is there a holding tank for the WFI
system, is it fitted with a sterilizing
grade vent filter that is integrity tested?
If WFI is stored on a continuous
circulation, is it held at > 80C? If not
circulated, is it discarded every 24
hours or diverted for suitable use?
If WFI used as a lubricant on the
recirculation pumps?
Are all the dead-legs within acceptable
length?
c.
4
a.
b.
5
a.
b.
c.
d.
e.
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Audit Item
2
a.
b.
c.
d.
Page 10 of 32
INSPECTION OF:
Date:
Audit Item
e.
f.
g.
h.
i.
j.
k.
l.
3
a.
b.
c.
4
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 11 of 32
INSPECTION OF:
Date:
3.0 A: Adequacy
#
Audit Item
Is the equipment
appropriately
designed, constructed and maintained?
Are steps taken to prevent any
substances required for operation, such
as lubricants or coolants, from coming
in contact with in-process or finished
products?
Are equipment surfaces that contact
components or products of a noninteractive nature?
Are process pipelines or service lines
whose contents come in contact with
products or product contact surfaces
sloped to allow proper drainage?
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Audit Item
5
6
7
8
Page 12 of 32
INSPECTION OF:
Date:
Audit Item
2
a.
b.
c.
d.
e.
f.
g.
3
4
5
6
7
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 13 of 32
INSPECTION OF:
Date:
Audit Item
a.
b.
c.
2
3
4
5
6
8
a.
b.
c.
d.
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 14 of 32
INSPECTION OF:
Date:
Audit Item
2
a.
b.
c.
3
a.
b.
c.
d.
e.
4
5
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 15 of 32
INSPECTION OF:
Date:
4.0 B: Processes
#
Audit Item
1
a.
b.
c.
2
a.
b.
3
a.
b.
c.
5
6
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 16 of 32
INSPECTION OF:
Date:
4.0 C: Sterilization/Depyrogenation
#
Audit Item
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
4.0 D: Identification
#
Audit Item
If a component/material is transferred
to a new container, is the new
contained identified with:
Component/material name or item
code?
Receiving or control number?
Amount in container?
Are dispensing/addition operations
adequately supervised in that each
component /material dispensed is
examined by a second person to ensure:
The component/material was released
by QC?
The amount agrees with the batch
record?
The container is properly identified?
The components/material are added in
the batch by one person and verified by
a second person?
Are actual yield and percentages of
theoretical yield determined at the
conclusion of each phase of operation
with documentation of any losses?
Are the yield calculations verified by a
second person?
Are all containers, lines and major
equipment identified at all times
production for content and phase of
operations?
a.
b.
c.
2
a.
b.
c.
d.
4
5
Page 17 of 32
INSPECTION OF:
Date:
Audit Item
10
11
12
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 18 of 32
INSPECTION OF:
Date:
5.0 A: Adequacy
#
Audit Item
2
3
4
a.
b.
c.
d.
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 19 of 32
INSPECTION OF:
Date:
Audit Item
Yes
No
NA
Observations (indicate
N.O. if not observed)
No
NA
Observations (indicate
N.O. if not observed)
Audit Item
Are
the
accuracy,
sensitivity,
specificity and reproducibility of test
methods established, documented,
validated and subject to regular review
and updating?
Is there a written testing programme
designated to assess the stability
characteristics of each product to
determine the appropriate storage
conditions and expiration dates?
Is there a retention sampling system?
Does the retention sample quantity
consist of at least twice the quantity
needed to perform all required tests
(except for sterility and pyrogens)?
Any retention samples of each lot of
final product stored under conditions
consistent with product labeling?
Are these samples at least visually
examined annually for evidence of
deterioration? Is this recorded?
3
4
Yes
Page 20 of 32
INSPECTION OF:
Date:
6.0 A: General
#
Audit Item
1
a.
b.
c.
d.
e.
f.
2
a.
b.
c.
d.
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Audit Item
1
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.
m.
n.
Page 21 of 32
INSPECTION OF:
Date:
Audit Item
o.
p.
q.
r.
2
a.
b.
c.
d.
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Audit Item
2
3
Page 22 of 32
INSPECTION OF:
Date:
7.0 A: Procurement
#
Audit Item
Are
there
SOPs
for
animal
procurement?
Is a specific individual in department,
authorized to order animals?
Do contracts with supplies assure the
quality and consistency of the animals
provided?
If the animals come from the
manufacturers own breeding colony,
are there SOPs for the maintenance and
testing of the colony?
2
3
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Audit Item
2
3
7.0 C: Care
#
Audit Item
2
3
Audit Item
Page 23 of 32
INSPECTION OF:
Date:
7.0 E: Facilities
#
Audit Item
a.
b.
c.
d.
e.
8
9
10
11
12
13
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 24 of 32
INSPECTION OF:
Date:
8.0 A: General
#
Audit Item
2
3
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
8.0 B: SOPs
#
Audit Item
3
4
8.0 C: Equipment
#
Audit Item
2
3
Page 25 of 32
INSPECTION OF:
Date:
Audit Item
1
2
3
4
5
6
7
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Audit Item
Page 26 of 32
INSPECTION OF:
Date:
Audit Item
2
3
4
5
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
8.0 G: Inspections
#
Audit Item
Page 27 of 32
INSPECTION OF:
Date:
Audit Item
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 28 of 32
INSPECTION OF:
Date:
Audit Item
10
11
12
13
14
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 29 of 32
INSPECTION OF:
Date:
Audit Item
5
6
Yes
No
NA
Observations (indicate
N.O. if not observed)
Page 30 of 32
INSPECTION OF:
Date:
Audit Item
2
3
4
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
10.0 B: Equipment
#
Audit Item
Page 31 of 32
INSPECTION OF:
Date:
Audit Item
Yes
No
NA
Observations (indicate
N.O. if not observed)
Yes
No
NA
Observations (indicate
N.O. if not observed)
Audit Item
Are
there
standard
operating
procedures for decontamination of
process equipment and facilities? Have
these procedures been validated and is
the performance monitored?
Is the equipment tested regularly for
integrity of containment capability?
Are standard operating procedures
available and displayed outlining
emergency procedures in the event of a
spill or accidental release of
contaminate?
Is there a list displayed of responsible
individuals to be contacted in the event
of an emergency?
Do personnel have specific training in
the procedures for handling the
pathogenic agents used and the method
of using containment equipment?
Are there SOPs for dress codes
specified for containment levels
applicable and is access controlled and
secured? Is there a list displayed of
authorized staff for entry?
Are
showers
available
where
applicable?
Is there a health and medical
surveillance program?
Are biohazard signs used and posted
where applicable?
Are SOPs available for the transport of
microorganisms in closed systems or
containers to and from the area?
2
3
7
8
9
10
Page 32 of 32
INSPECTION OF:
Date:
11.0 A: General
#
Audit Item
1
a.
b.
c.
d.
e.
f.
2
3
4
5
a.
b.
c.
d.
e.
f.
6
Yes
No
NA
Observations (indicate
N.O. if not observed)