PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 311

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

Inappropriate materials
of construction, e.g.,
produces lint

Product contaminated
with particulate, failed
product quality

Cleaning
frequency

Insufficient frequency to
keep contaminants at
controllable level

High levels of
contamination, product
contamination

Environmental
control

Room air quality
requirements

Inappropriate air quality
require-
ments/classification for
room's intended
purpose

Inadequate controls in
place, product
contamination

Air filtration
system

Inadequate air filtration
to keep environment
clean of air-borne
contaminants

High levels of air-borne
contaminants, product
contamination

Air pressure Inadequate air pressure

or incorrect air flow
design

Introduction of
contaminate into room;
product contamination

Light protection Inadequate light

protection for
light-sensitive product

Product degradation,
instability

Temperature/
humidity

Inadequate temperature
or humidity control

Condensate in room,
increased microbial
bioburden levels,
hygroscopic or
temperature sensitive
product
degradation/instability

Insufficient monitoring of
room environment (air
particles, temperature,
humidity)

Product
contamination/inability
to correct issue in
timely manner

Equipment/
Instruments

Fit for
purpose

Correct
instrument or
equipment
needed for job

Inappropriate sensitivity
used for application
(e.g., balance
measuring to only one
decimal when three
decimals are needed)

Inadequate or inaccurate
measurements, product
quality, potency,
stability compromised

Incapable of meeting
required operating
parameters

Incomplete process step

Size Different size than

required, e.g., smaller
bulk formulation tank

Improper product
formulation, e.g.,
mixing,
nonhomogeneous bulk

Model or design Different model or
design than required

Improper product
formulation or filling
operation

( continued )