1
Q
ICHQ10
A
Pharmaceutical Quality Systems
2
Q
ICHQ8
A
Pharmaceutical Development QbD (similar parts in CFR 21 Part 280)
3
Q
QTPP
A
Quality Target Product Profile
4
Q
CQAs
A
Critical Quality Attributes
5
Q
Risk =
A
probability x severity of harm
6
Q
Six-System Inspection Model
A
Quality System
- Production System
- Facilities & Equipment System
- Laboratory Controls System
- Materials System
- Packaging and Labeling System
7
Q
Quality Control CFR, ICHQ, EU Directive?
A
- CFR 211 Subpart B Organization & Personnel
- ICHQ7
- 2001/83/EC
8
Q
4 Requirements for a robust quality system
A
- management responsibilities
- resources
- manufacturing operations
- evaluation activities
