pharmaceutical circles, not merely due to strong persuasion from the International

Council for Harmonisation (ICH), but its subsequent ratification from key regulatory

agencies like the US Food and Drug Administration (US-FDA), the World Health

Organization (WHO), the European Medicines Agency, and several others, testified

by their corresponding regulatory guidance documents (Singh 2014; Aksu et al.

2015; Singh et al. 2017a, b).

QbD is almost an obligatory catchword today all across the pharmaceutical sector

of the globe, accentuating on building quality into the system all through the product

development cycle, without relying on terminal testing of the products (ICH

Harmonised Tripartite Guideline 2009; Singh 2014; Aksu et al. 2015; Beg et al.

2019). Incorporating the principal elements of Design of Experiments (DoE) and

quality risk management (QRM), QbD chiefly undertakes science- and risk-based

approaches to hit on categorical product and process comprehension (ICH

Harmonised Tripartite Guideline 2005; Singh 2014). Hence, QbD is a rational

amalgam of QRM- and DoE-based pharma production while endeavouring to

unravel to gain all-inclusive process and product understanding. This has lately

become a routine practice in pharma industry, institutional research and regulatory

compliance (Singh 2014; Djuris and Djuric 2017).

Verily, the QbD precepts are based upon J.M. Juran’s quality philosophy, to

produce quality products and deliver services by pre-planning of their quality and

avoiding any issues at the final stages of production phase (Yu et al. 2014; Aksu et al.

2015; Montgomery 2001; Singh et al., 2005b, 2013). The benefits of QbD have not

only been harvested towards unearthing the science underlying the process of

product

development

but

also

of

analytical

development,

drug

substance

manufacturing, dissolution testing, bioavailability studies and biologicals. Owing

to much vaster purview of QbD applications today, a pithier term, viz. “Formulation

by Design (FbD)”, was proposed a few years ago by us, germane precisely to the

practice of QbD principles in developing drug delivery products (Singh et al. 2011c).

Figure 18.2 elucidates the vital implements of FbD, which comprise not only

Fig. 18.2 Cardinal elements

of Formulation by Design

(FbD)

18

QbD-Steered Systematic Development of Drug Delivery Nanoconstructs:. . .

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