Study Set Content:
Quality measured by
testing and inspection
Current approach
Quality built into the
product
QBD Approach
Data intensive submission
Current approach
Specification based on
batch history
Current approach
Frozen process
discouraging changes
Current approach
Knowledge rich submission
QBD Approach
Specification based on
product performance
requirements
QBD Approach
focus on reproducibility
CURRENT APPROACH
Flexible process within
design space, allowing
continuous improvement
QBD APPROACH
Focus on robustness
QBD APPROACH
Weighing, Mixing
68 to 72°F (20 to 22°C)
Compression
68°F (20°C)
Pan coating
53 to 203 F (12 to
10 to 70% RH
95°C)
Filling and Packing
68°F (20°C)
Storage
68 to 77°F (20 to 25°C)
Weighing, Mixing
Humidity
35 to 40% RH
68°F (20°C)
25 to 35% RH
Pan coating
10 to 70% RH
Filling and Packing
10 to 35% RH
Storage
45% RH
