PROCESS LIFECYCLE VALIDATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 194

TABLE 8.7 Example of Risk Assessment for Cause/Effect Process Parameter and Identification of CPPs

Recommended

Parameter/ Acceptable Failure Severity Frequency RI Risk Control

Control Range Mode Effect Cause Controls ( S ) ( F ) (S*F) Actions Decision

Press
speed

30-70
rpm

Out-of-range
speeds
(high or
low)

Can give
nonuniform
tablet
weights,
thicknesses,
friability,
and
hardness,
impacting
product
potency, and
dissolution

Machine
speed
con-
trolled
by
operator
(man-
ual)

1) Defining press
set-point and
monitoring of
press and
tablets,
2) Press
verification or
qualification,
3) Tablet tests at
various press
speeds

8 3 24 Perform

continuous
monitoring,
alarms

Not CPP

Feeder
speed

60-100
rpm

Out of range
(high or
low)

Impacts tablet
weight, but
no impact to
product
quality

Machine
speed
con-
trolled
by
operator
(man-
ual)

1) Feeder
verification or
qualification,
2) Tablet tests at
various feeder
speeds,
3) Defining
feeder
set-point and
monitoring of
feeder and
tablets

2 7 14 Perform

continuous
monitoring of
tablet
characteristics
with
adjustments
made to
ensure
required
product
characteristics
are met

Not CPP

( continued )