POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 151

Critical
quality
attributes
(CQAs)

Process
steps
which
affect CQA

Test functions
and
acceptance
criteria

Operating
variables and
parameters

Systems and
conditions

Prove the
process is
capable

What could go wrong,
(failure) and affect
CQA?

What is
critical?

How is it achieved?

1. Category 2. CQA 3. Process step 4. System 5. Function 6. Test

Sterility
Endotoxinfree
Contamination free
Potency
Weight/volume

Filtration
Component
Sterilization
Depyrogenation
Mixing
Cleaning
Printing
Cartoning

Filter
Transfer lines
Tunnel
Reactor vessel
Clean in place
Ink jet
Cartoner

Microbial retention
Filter integrity
Condensate
Temperature/time
Agitator speed
Flow, pressure,
Temperature
Software
Mechanical function

Filter challenge
Temperature
Distribution
Biological indicator
Challenge
Tachometer
Flow and pressure-
calculation and
testing
Computer system
validation
Operational
qualification

Safety

Strength

Purity

Foreign substance

Contamination free
Labeling
Insert included
Lot number

Identity

Figure 7.4 Qualification sequence.

155