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

Hashim, Yumi Zuhanis Has-Yun and Abbas, Phirdaous and Samsudin, Nurhusna and Jamaludin, Mohammad Aizat and Mahamad Maifiah, Mohd Hafidz (2026) Operationalizing halal assurance within the quality-by-design pharmaceutical development lifecycle: a conceptual framework for biopharmaceutical development. Halalsphere, 6 (2). pp. 96-101. E-ISSN 2773-6040

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Abstract

Halal assurance is increasingly recognized as an important consideration in biopharmaceutical 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.

Item Type:	Article (Journal)
Uncontrolled Keywords:	Quality-by-Design (QbD), Halal assurance, Biopharmaceuticals, Pharmaceutical development, Conceptual framework, Pharmaceutical quality system
Subjects:	BPC Science and Technology in Islam
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button):	International Institute for Halal Research and Training (INHART)
Depositing User:	DR YUMI ZUHANIS HAS-YUN HASHIM
Date Deposited:	12 Aug 2026 11:15
Last Update:	12 Aug 2026 11:15
Queue Number:	2026-08-Q4667
URI:	http://irep.iium.edu.my/id/eprint/130709

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