BIOPHARMACEUTICAL MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 354

TABLE A.1 Hazard Analysis: FBS Utilization
No.

Hazard Cause Harm Severity Likelihood Risk Mitigations

1 Contamination,

microbiological

Serum collection does
not comply with
applicable protocols

Death High Low As low as

reasonably
practical

Supplier quality audit indicates
compliance with all applicable
regulations

2 Serum collection by

untrained personnel

Supplier quality audit indicates
compliance with all applicable
regulations

3 FBS processing does

not comply with
cGMPs

Certificate of Conformance
indicates compliance with
requirements

4 Irradiation dose too

low to inactivate
microorganisms

Irradiation process validated and
monitored
Certificate of Irradiation
provided with each lot

5 Testing does not

comply with
European
Pharmacopeia
requirements

Material tested in compliance
with regulations after
irradiation

6 Contamination,

prions, for
example, TSE

Serum collection does
not comply with
applicable protocols

Death High Low As low as

reasonably
practical

Country of origin complies with
GBR level 1 requirements as
specified by the EFSA
A Certificate of Suitability is
available for all lots