This document outlines the key steps for generic drug product development using a Quality by Design (QbD) pathway, including supplier selection, API and excipient compatibility studies, process development from lab to pilot to pivotal scale, formula optimization at each stage, manufacturing demonstration batches, biostudies, stability testing, and e-CTD regulatory submission with defined quality target product profile, critical quality attributes, critical material attributes, and control strategy.

1. Supplier selection (API/Excipients/Packing material)
Innovator samples /API characterization
API/Excipients compatibility studies
Initial risk assessment
Process selection
Lab scale manufacturing process development
Formula finalisation
Scaleup from lab to pilot scale
Pilot scale manufacturing process development
Demo Pilot batch
Manufacturing
Biostudies #
Stability *
Scaleup from pilot to pivotal batch
Demo pivotal batch
Manufacturing
Biostudies
stability
Lab scale
formula
optimisation
Pilot scale
formula
optimisation
Pivotal
scale/Exhibit
batch
Development inititation
e-CTD submission
Generic product development with QbD pathway
QbD pathway
QTPP
CQA
CMA/CPP
DOE
DS
Control strategy
Continuous
monitoring
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