PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 307

Appendix I: List of Potential Risks Associated with Drug Product
Manufacture
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

Packaging is not intact
and not tamper evident

Contaminated or
tainted/adulterated
materials

Packaging not dry Moisture damage,

contamination of
materials

Packaging not clean Contamination of

materials

Required environmental
conditions not
maintained

Loss of material's
potency/stability

Procedures do not
address material
disposition and
management
notification for
deviations

Use of inappropriate
materials. Continued
problems with quality
of received materials

Design of
receiving areas

Ingress of environmental
elements such as rain,
wind, animals, or
insects

Contamination of
materials and/or
infestation of staging
and storage areas

Standing water or excess
moisture

Potential for microbial
(mold) proliferation, or
contamination of
materials

Material handling
procedures

Practices not designed to
prevent damage to
packaging,
contamination

Materials can be exposed
to environmental
conditions and
contamination

Environmental
storage
conditions

Required environment
conditions are not
maintained. Adequacy
of temperature and
humidity control
depends on season of
year.

Loss of material's
potency/stability. Lots
do not meet incoming
specifications for
critical quality
attributes

Procedures address
material disposition
and management
notification for
deviations

Use of substandard
materials, failed
product quality

Material status Adequate identification

and/or separation of
different material
status (i.e., quarantine,
release, rejected)

Use of rejected or
quarantined materials
in a released batch

( continued )