Box 18.2 (continued)

Term

Precise explanation

Continuous

improvement

Monitoring the process capability to reproduce the product

quality

18.4.5 Step V: Industrial Scale-Up Studies and Production

In order to ascertain the reproducibility and validate the QbD performance

demonstrated during laboratory experimentation, the drug delivery products, while

in an industrial setup, have to undergo a strategic scale-up process extrapolating

laboratory scale outcomes through pilot plant studies to production scale (Houson

2011; Singh et al. 2017a, b; Khurana et al. 2018).

Control strategy is a premeditated control set, attained from current product and

process understanding, to ensure the anticipated process output and product perfor-

mance. Incorporating various controls to ensure product quality, control strategy

aims to pave the way towards continuous improvement in the quality of drug

products (Shah et al. 2015; Singh et al. 2018a). Continuous improvement is the

final component of the QbD process, serving as feedback-control mechanism of

operations, integrating all the process knowledge for the purpose. This leads to

improved product and process understanding at all the production levels, thereby

accomplishing product quality excellence as well as requisite regulatory compliance.

18.5

FbD of Drug Nanoconstructs

Albeit QbD nowadays has pervaded to nearly all the realms of healthcare sector,

sufficient scope still exists for extrapolating its varied applications in quite intricate

strategies of nanomedicines. It is, for that matter, that the global pharmaceutical

world, particularly since the last few decades, has been witnessing mounting adop-

tion of QbD in the development of nanopharmaceutical products. Employing the

vast rewards of implementing FbD paradigms, practically all of the foremost types of

drug nanocarriers have been reported to be rationally and systematically developed

(Bhavsar et al. 2006; Singh et al. 2011c, 2015, 2017a,b; Kanwar and Sinha 2019).

Earnest endeavours, accordingly, have been undertaken to deliver a categorical

yet pithy overview of latest literature reports of the recent 5 years, endeavouring

principally on the development of various drug nanoconstructs employing FbD.

Besides, the chapter also furnishes a rational insight into various CMAs, CPPs and

CQAs explored and different experimental designs used for achieving the

anticipated quality targets. On the basis of the types of constitution of various drug

delivery nanocarrier systems, the pertinent pictographic representations have been

18

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

327