Establishing a Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) for Continuous Hot-Melt Extrusion of Oral Solid Dosage Forms

The pharmaceutical manufacturing industry faces increasing regulatory and commercial pressure to transition from traditional batch-based production toward continuous manufacturing (CM) platforms that deliver superior process consistency, reduced cycle times, and proactive quality assurance. Oral Solid Dosage (OSD) forms, representing approximately 65% of all pharmaceutical products globally, stand at the forefront of this transformation. Twin-screw granulation (TSG) has emerged as the most widely adopted continuous wet granulation technology; however, its multi-parametric nature demands a rigorous, science-driven development framework. Quality by Design (QbD), formalized under ICH Q8(R2) and supported by ICH Q9, Q10, and Q12, provides precisely such a framework — enabling manufacturers to design quality into products and processes from the earliest stages of development rather than testing for it retrospectively at batch completion.