Operationalizing halal assurance within the quality-by-design pharmaceutical development lifecycle: A conceptual framework for biopharmaceutical development

development. However, existing halal assurance and regulatory frameworks remain largely focused on organizational governance, material compliance, certification, traceability, and risk management, without explicitly operationalizing halal assurance within the Quality-by-Design (QbD) pharmaceutical development lifecycle. This Short Communication proposes a conceptual framework that operationalizes halal assurance across each stage of the QbD lifecycle, from the Quality Target Product Profile (QTPP) through Product Lifecycle Management. Rather than introducing a separate halal management framework, the proposed framework complements existing halal governance by embedding halal assurance within established pharmaceutical quality principles, thereby providing a practical foundation for systematic, proactive, and lifecycle-oriented halal biopharmaceutical development.