BIOPHARMACEUTICAL MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 355

TABLE A.1 ( Continued )

No. Hazard Cause Harm Severity Likelihood Risk Mitigations

7 Serum collection by

untrained personnel

Country of origin complies with
GBR level 1 requirements as
specified by the EFSA

8 Contamination,

particle

Serum collected in
contaminated vessels

Process failure Low Low Broadly

acceptable

FBS filtered to remove
particulates prior to irradiation

9 FBS out of

specification

Testing does not
comply with
European
Pharmacopeia
requirements

Medium does
not support
cell growth.

Low Low Broadly

acceptable

Supplier Quality audit confirms
compliance with regulations
Certificate of Conformance
indicates compliance with
requirements

10 FBS processing does

not comply with
cGMPs

Process failure Low Low Broadly

acceptable

11 FBS degraded Irradiation dose too

high

Medium does
not support
cell growth.

Low Low Broadly

acceptable

Supplier Quality audit confirms
compliance with regulations