PROCESS LIFECYCLE VALIDATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 195

TABLE 8.7 ( Continued )

Recommended

Parameter/ Acceptable Failure Severity Frequency RI Risk Control

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

Overload
setting

Maximum
40 K
Newtons
(NOR)

Higher Potential

impact to
tablet
weight,
hardness,
thickness,
friability

Machine
set-up
error

Compare tooling
specs versus
press overload
capability and
controls;
Manuf. Batch
Record check

8 3 24 Determine

specific
maximum
force allowed
to avoid
tooling
damage; verify
proper
machine set-up

Not CPP

Spray rate Total
380-420
g/min
for all
guns

Out of range
(high or
low)

High spray rate
may impact
tablet
appearance
and
dissolution.
Low spray
rate extends
coating
process times
but not
critical to
product
quality.

Spray rate
gov-
erned by
auto-
mated
controls
with
limit
alarms

Spray gun nozzle
size, and
number of
guns
placement
defined and
controlled

8 7 56 Rate periodically

verified within
range by
operator;
confirm
control
strategy and
regulatory
commitment

CPP