PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 309

Appendix I: ( Continued )

Major Area Subarea(s) Potential Hazard Potential Harm

Raw Material Materials Use of Wrong Material or

Materials Management on Receipt: Inadequate Identification Wrong Grade of Material

Compressed gases Inappropriate venting or
use of compressed
gases

Impacts environment,
product contamination

Drying Operating

parameters

Inadequate drying May impact product

stability, unable to
further process

Wet holding time Inadequate control of wet
holding times

Wet conditions could
allow chemical
reactions to take place,
degrading or changing
bulk composition

Milling Operating

parameters

Inadequate sieving Nonhomogenous

granules, product
quality compromised

Equipment setup Wrong screens Clumps not eliminated as

needed

Equipment Warped screens Contamination with

metal particulate

Mixing/
blending

Blending
operating
parameters

Inadequate
mixing/blending

Nonhomogeneous batch;
variable or incorrect
finished product
potency

Materials Wrong material Mislabeled product;

patient safety

Wrong amount of
material added

Bulk quality, affects
compression process

Finish
Processing

Compression Bulk flow Inaccurate amount

measured to be
compressed

Mislabeled product,
subpotent or
superpotent product

Environmental
conditions

Humidity is not
adequately controlled

Powder absorbs moisture
and cakes preventing
adequate flow

Hardness-
friability

Incorrect compression
parameters

Chipping or flaking off,
susceptible to further
cracking

Equipment setup Wrong punches or dyes Inadequate product

quantity, weight
variation

Punches are out of
alignment

Parts shed metal
contaminating product

Film Coating Coating material Incorrect solution

preparation (e.g., too
thick or thin)

Inadequate or uneven
application; product
degradation or
instability

Equipment Spray nozzles are

clogged

Inadequate coating;
product degradation or
instability

( continued )