Biomedical Engineering Reference
In-Depth Information
Appendix I: (
Continued
)
Major Area
Subarea(s)
Potential Hazard
Potential Harm
Raw
Material
Materials
Use of Wrong Material or
Materials
Management
on Receipt:
Inadequate Identification Wrong Grade of Material
API/
Excipient/
Water
Quality
Incoming lot
quality
Lot-to-lot variability in
quality characteristics
such as moisture
content and microbial
bioburden
Lots do not meet
incoming
specifications for
critical quality
attributes. Use of
materials impact the
outgoing quality of the
product
Incoming lot monitoring
program is inadequate
to monitor incoming
quality
Use of substandard
materials, failed
product quality
Supplier man-
agement
Supplier
management
program
Supplier management
program does not exist
or is inadequate
Inconsistent incoming lot
quality. Use of
substandard materials,
failed product quality
Formulation
Equipment
Substituted equipment:
incorrect design, size,
or incapable to run
required operating
parameters
Inadequate or incorrect
granulation, milling, or
blending. Product
quality compromised
Dispensing
Materials
Incorrect raw materials
weighed or measured
Incorrect batch
composition;
mislabeled product;
patient safety
Material labeling Materials incorrectly
labeled
Incorrect batch
composition, not
delivering on intended
use, patient safety
Measurement/
weighing
Inaccurate measurement Mislabeled product,
subpotent or
superpotent product
Material delivery Incorrect raw materials
delivered to
formulation area
Mislabeled product, not
delivering on intended
use; product safety
Granulation Material addition Materials added in
incorrect sequence,
amounts per addition,
or timing between
additions
Improper formulation,
product instability, or
incorrect potency
Operating
procedures
Inadequate (e.g., every
step not defined),
incorrect written
instructions
Improper formulation;
product instability or
incorrect potency
Equipment
Incorrect chopper or
mixing blades
Improper product
formulation
Search WWH ::
Custom Search