Biomedical Engineering Reference
In-Depth Information
TABLE 11.4 HACCP Control Chart Example
HACCP Control Chart
Microbiological Control for Tablet Compression in Non-Sterile Manufacturing
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
Microbial
Preventive
Critical
Monitoring
Corrective
CCP
Hazard
Measure
Levels
What
How
Frequency
Who
Action
Record
CCP #4.1 dry
step
Tablet press
is wet
Heated air
30 min
30 min
Timer
Check timer
SOP #101
Start of each
drying
step
Online staff Repeat dry
step
Batch record
300
◦
F
heated air
Alarm
sounds at
air temp.
of 300
◦
F
≥
Temp. chart,
alarm
Check chart,
SOP #102
test alarm
SOP #105
Start of each
batch
Online staff PM on
alarm,
temp.
device,
heat
source
Batch record
temp.
chart
Operator
verifies
dryness
Dry
Tablet press Visual SOP
#104
End of
drying
step
Online staff Repeat dry
step.
Batch record
Product:
Date:
Signature(s):
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