Quality- by-design in pharmaceutical development - Computer-Aided Applications in Pharmaceutical Technology - page 7

Control
strategy

- Drug product quality
controlled primarily by
intermediates (in-
process materials) and
end-product testing

- Drug product quality ensured by
risk-based control strategy for well
understood product and process
- Quality controls shifted upstream,
with the possibility of real-time
release testing or reduced
end-product testing

Lifecycle
management

- Reactive (i.e. problem
solving and corrective
action)

- Preventive actions
- Continual improvement facilitated

1.3 Regulatory and industry
views on QbD

Since the introduction of the Food and Drug Association (FDA) 21st-
century initiative (A Risk-Based Approach) in 2004, early adoption of
new technologies, and risk based approaches in pharmaceutical product
development, are encouraged (FDA, 2004). As defi ned by an FDA offi cial
(Woodcock, 2004), the QbD concept represents product and process
performance characteristics scientifi cally designed to meet specifi c
objectives, not merely empirically derived from performance of test
batches. Another FDA representative (Shah, 2009) states that introduction
of the QbD concept can lead to cost savings and effi ciency improvements
for both industry and regulators. QbD can facilitate innovation, increase
manufacturing effi ciency, reduce cost/product rejects, minimize/eliminate
potential compliance actions, enhance opportunities for fi rst cycle
approval, streamline post approval changes and regulatory processes,
enable more focused inspections, and provide opportunities for continual
improvement (Shah, 2009). The FDA has provided examples on
implementation of QbD concepts in abbreviated new drug applications
(ANDA) for both immediate and modifi ed release dosage forms.
Illustrative examples can be obtained through the FDA web site, presented
in the form of section 3.2.P.2 Pharmaceutical Development part of CTD
fi le Module 3 (Quality). Pharmaceutical development of acetriptan
immediate release and an example of modifi ed release tablets are
presented. 1
European Medicines Agency (EMA) representatives (Korakianiti,
2009) stressed that it is the uncontrolled variability in, for example,

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