Introduction
Since decades, the pharmaceutical
products have been considered as the
highly regulated products meant for human
use for accomplishing desired therapeutic
benefits for treatment of diverse ailments.
Despite continuous innovations by the
pharma industry, there has been a repeated
set back owing their poor quality and
manufacturing standards. The adoption of
systematic approaches has been originated
from a thought provoking article that
appeared in The Wall Street Journal more
than a decade back (i.e., September 2002)
was an eye opener for the federal agencies.
It stated that “although the pharmaceutical
industry has a little secret even as it invents
futuristic new drugs, yet its manufacturing
standards lag far behind the potato chips
and laundry soap makers” [1]. Figure 1
portrays multiple sources of variability
during drug product development owing to
variability in drug substance(s),
excipient(s), process(es), packaging
material(s), etc.
Figure 1: Sources of myriad variability
during drug product development
With the consequent growing concern and
criticisms, the ICH instituted a series of
quality guidances like Q8, Q9, Q10 and