Biomedical Engineering Reference
In-Depth Information
TABL E 10.4. An Example of an FMEA Application to the Drug Product Characteristic “Excipient”
Characteristic
(Main Branch)
Potential
Failures
Potential Effects
Potential Causes
O
S
D
RPN
Action Required
Excipients
Not in right
amount
OOS/stab failure
Variability during manufacture in
weighing large volumes
6
5
8
240
Assess acceptable ranges.
Identify critical
excipients to control
Incorrect amount added
1
5
1
5
Batch records
Not of right
quality
OOS/stab failure
Not in spec
1
5
1
5
QC control
Aged raw material (RM)
8
8
5
320
Assess impact of range of
spec on critical attribute
of critical RM
TABL E 10.5. An Example of an FMEA Application to the Drug Product Process Characteristic “On-Line Filtration by N
2
Pressure”
Characteristic
(Main Branch)
Potential Failures
Potential Effects
Potential Causes
O S D
RPN
Action Required
On-line filtration
by N
2
pressure
Adsorption of
excipient 1 during
machine stop
Product not
homogeneousexcipient
1 concentration too low
Inappropriate
membrane, long
stand-time of
solution in filter
5 8 8
320 Adsorption tests as part of filter
selection; process robustness
testing; simulated machine stop
studies; process validation
Adsorption of
protein during
machine stop
OOS assay
result
Inappropriate
membrane, long
stand-time of
solution
3 8 5
120 Adsorption tests as part of filter
selection; process robustness
testing; simulated machine stop
studies; process validation
