PROCESS DEVELOPMENT AND CLINICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 113

TABLE 6.6 ( Continued )

Controls

Failure Cause in place

# Mode of Failure Effect Controls Comments Yes/No

4. Lack of
adequate
work
areas

Mix-up/
contamination or
cross-
contamination

Product unsafe Risk mitigated and acceptable YES

• Facility designed to allow
adequate space for
operations, ease of cleaning
and maintenance
• Facility operated as a suite
i.e., only the active (API) to
be used in the clinical trial
can be exposed in the facility
from the time of initiation of
the manufacture of the
clinical trial batch. This
includes sampling and
weighing of starting materials
• Rigorous, documented
cleaning and line clearance
before the start of the
above-mentioned campaign

5. Shared

facility
unsuitable

Air handling system
lets R&D
material carry
into drug product
for human use

Cross-
contamination

R&D facility can continue
uninhibited
GMP facility is protected
provided controls are
enforced and monitored
Risk mitigated once facility is
commissioned and SOPs are
in place.

YES

• Separate facility for activities
for human use
• Restricted access (coded)
• Sealed rooms in GMP facility
• Fan Filter Units with HEPA
filtration on incoming air in
GMP facility