PROCESS DEVELOPMENT AND CLINICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 119

TABLE 6.6 ( Continued )

Controls

Failure Cause in place

# Mode of Failure Effect Controls Comments Yes/No

15. Lack of

adequately
controlled
procedures

Labeling mix-up Mislabeled

product

• Very small quantities handled
per batch
• GMP facility operates as a
dedicated suite during the
campaign
• Documented reconciliation of
labels (from issuance through
use and destruction)

Risk mitigated/acceptable YES

16. Lack of

adequately
controlled
procedures

Distribution of
product
inadequately
controlled

Poor quality
product

Risk mitigated/acceptable YES

• Product to be used for initial
trial is not temperature
sensitive and packaging will
be adequate to ensure quality
through delivery to trial sites
within a 25 km radius (one,
local site only)

17. Lack of

adequately
controlled
procedures

Failure to retain
batch
sample/place
batch on
stability

Inability to
conduct
investigations

Risk acceptable YES

• SOP for sample retention
• Stability protocol at least for
duration of the trial and
qualified test methods shown
to be stability indicating