PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 314

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

Intervention/
interaction
with
product,
components

Operator
techniques

Procedures are not
designed to avoid
operator contact with
product (e.g., operator
uses hands to reach
into or leans over open
container

Product contamination

Operator
behaviors

Procedures do not define
operator behaviors that
avoid product
contamination (e.g.,
operator leave doors
open between rooms of
different air pressures)

Product contamination

Training Appropriate

training

Training not associated
with tasks performed

Untrained personnel
incorrectly performs
step, product quality
impacted

Effective training Inappropriate training
technique

Training incomplete,
incorrectly performs
step impacting product
quality

Training records
archive and
retrieval

Poor documentation of
training and
uncontrolled storage.
Inability to review
training to assess
training needs

May assign untrained
person to perform task;
step incorrectly
performed impacting
product quality

Performance
monitoring

Inadequate monitoring,
training needs not
assessed

Incorrect step
performance impacts
product quality

GLOSSARY

The following definitions are provided to aid understanding:

Critical quality attribute (CQA) : A physical, chemical, biological, or micro-
biological property or characteristic that should be within an appropriate
limit, range, or distribution to ensure the desired product quality [14].
Critical control point (CCP) : A process parameter whose variability has an
impact on a critical quality attribute and therefore should be monitored or
controlled to ensure the process produces the desired quality [14].