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shelf life; tablets should be robust in order to withstand transport and
handling, and a suitable size to aid patient acceptability and compliance.
According to the defi ned QTPP, CQAs may include assay, content
uniformity, dissolution, and degradation products, whereas CPPs could
be the compression force and speed used for tableting.
The multidimensional combination and interaction of input variables
(e.g. material attributes) and process parameters that have been
demonstrated to provide assurance of quality is denoted as the design
space. The emphasis of the ICH Q8 guideline is to shift pharmaceutical
product development from the empirical, trial-and-error approach, to the
scientifi cally based process of design space appointment. Defi nition of
design space also requires implementation of various risk management
tools, as well as defi nition of specifi cations and manufacturing controls.
Figure 1.1 shows a diagram of a QbD approach, combining design space
development and risk management tools.
Implementation of the QbD concept is important for all products,
including generics and biotechnological products (Nasr, 2011). There are
detailed reports on pharmaceutical QbD (Lionberger et al., 2008; Yu,
2008). The reader is advised to consult relevant textbooks on regulations
and quality in the pharmaceutical industry (Gad, 2008), QbD concept in
chemical engineering in the pharmaceutical industry (Am Ende, 2010),
application of QbD in biopharmaceuticals (Rathore and Mhatre, 2009),
QbD issues in process understanding for scale-up and manufacture of
active ingredients (Houson, 2011), as well as upcoming reviews on QbD
in pharmaceutical and biopharmaceutical development (Herwig and
Menezes, 2013; Reklaitis, 2013). Furthermore, links between process
analytical technology (PAT) and QbD are elaborated on (Bakeev, 2010),
with special emphasis on biopharmaceuticals (Undey et al., 2012).
1.2 ICH Q8 guideline
The ICH Q8 guideline on scientifi cally based pharmaceutical development
serves to provide opportunities for pharmaceutical manufacturers to seek
regulatory fl exibility and mitigation of some activities required for product
registration and/or subsequent post approval change process. The ICH
Q8 guideline describes good practices for pharmaceutical product
development. Working within the defi ned design space is not recognized
as the change that would require regulatory approval. This paradigm can
be used to signifi cantly improve productivity and quality assurance in the
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