PROCESS DEVELOPMENT AND CLINICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 112

TABLE 6.6 Preliminary Risk Assessment for Phase 1 Clinical Trial

Controls

Failure Cause in place

# Mode of Failure Effect Controls Comments Yes/No

• Work only with solid, oral
dosage forms: no sterile
products

1. Facility

unsuitable

HVAC system and
associated
controls

Product
contamination

Severity of failure of air
handling system significantly
reduced as no aseptic
processing and less
likelihood of contamination.
Risk acceptable

YES

2. Facility

unsuitable

Other potent
compounds in
facility

Cross-
contamination

Risk does not exist at present
and change control
procedure in place to capture
any change of the status quo
(e.g., R&D request to work
with a potent compound or
one of unknown toxicity)

YES

• Company does not work with
potent compounds at this
time, including for R&D
purposes
• GMP manufacturing facility
separated from R&D
activities

3. Facility

unsuitable

API to be used in
trial is potent or
unknown toxicity
profile

Unsafe product
or Operator
safety hazards

Risk does not exist and change
control procedure is in place
to allow for assessment if a
new trial with a different
API is planned

YES

• Company is working with
one, characterized API
ONLY at this time

( continued )