Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
1
No.
General:
Audit Item
No.
Audit Item
2.1
2.2
2.3
2.4
2.5
2.6
Observations / Remarks
Observations / Remarks
HVAC System:
No.
Audit Item
3.1
3.2
3.3
3.4
3.5
a)
b)
c)
d)
Observations / Remarks
3.7
3.8
3.9
3.1O
3.11
3.12
3.13
3.14
3.15
3.16
Environmental Monitoring:
No.
Audit Item
4.1
4.2
a)
b)
c)
d)
e)
f)
4.3
4.4
4.5
Observations / Remarks
4.7
4.8
Garments:
No.
Audit Item
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.1O
5.11
5.12
5.13
5.14
5.15
5.16
5.17
5.18
5.19
Observations / Remarks
6
No.
6.1
Sanitation:
Audit Item
Whether written procedures available for
sanitation of sterile processing facilities
Observations / Remarks
6.3
6.4
6.5
Equipment:
No.
Audit Item
7.1
A
B
C
D
E
F
G
H
I
J
K
L
M
N
7.2
Observations / Remarks
7.7
7.8
7.9
7.1O
7.11
7.12
7.13
8
No.
8.1
8.2
8.3
8.4
8.5
8.6
8.7
8.8
8.8.1
8.8.2
8.9
8.1O
8.11
8.12
8.12.1
Observations / Remarks
Manufacturing Process:
9.1
9.2
9.3
9.4
9.5
9.6
9.7
Sterilization(Autoclaving)
10. 10 Whether the sterilizing processes have been
validated( Dry heat, Moist heat, filtration, ETO,
ionizations whichever applicable.
10.11 Whether the validity of the process verified at
regular intervals (at least annually)
10.12 Whether significant changes made to the
equipment and / or the prodcut. Whether the
records of such changes maintained.
10.13 Whether sterilizer double ended.
10.14 Whether the terminal sterilizer's capacity is
sufficient to sterilize one batch completely at
one time. If not specify controls and measures
taken in lot sterilization
10.15 Whether the monitoring of products bio-burden
carried out before terminal sterilization.
10.16 Whether bio-burden controlled to the specified
limits in the Master Formula.
10.17 Whether biological indicators used in
monitoring of sterilization.
10.18 Whether the biological indicators stored and
used as per manufacturers instructions. Whether
quality of BI's checked by positive controls.
Audit Item
Observations / Remarks
12 Documentation:
No.
Audit Item
Observations / Remarks
10
23
24
25
26
27
28
29
30
31
32
33
34
13.1
13.2
13.3
13.4
13.5
11