PROCESS DEVELOPMENT AND CLINICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 117

TABLE 6.6 ( Continued )

Controls

Failure Cause in place

# Mode of Failure Effect Controls Comments Yes/No

12. Materials
unsuitable

Incoming material
fails to meet
specification or
specification not
sufficiently
robust

Contaminated
product

• Questionnaires received from
each manufacturer along with
detailed specifications
• Reputable suppliers/sources
used—located in countries
with recognized regulatory
systems in place
• COA received with every
batch of starting material

Residual risk
remains—on-site audit
would be preferable to
questionnaire especially
for API but not at this
stage
FDA phase 1 guidance [11]
allows identity testing
only; full COA testing to
be performed on API
batch used in the clinical
trial in lieu of site audit.
In addition, COAs for
each of the materials
(active and inactive) to be
used will be reviewed
and retained.

Risk mitigated
and residual
risk accepted

13. Materials
unsuitable

Lack of
traceability

Unsafe product Risk acceptable YES

• SOP for materials receipt
including receiving goods
logbook recording: receipt
date, quantity in shipment,
supplier's name, material lot
number, storage conditions,
and corresponding expiration
date