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

Authors

  • Yumi Zuhanis Has-Yun Hashim International Institute for Halal Research and Training (INHART), Level 3, Block A, KICT Building, International Islamic University Malaysia (IIUM), 53100, Selangor, Malaysia.
  • Phirdaous Bin Abbas International Institute for Halal Research and Training (INHART), Level 3, Block A, KICT Building, International Islamic University Malaysia (IIUM), 53100, Selangor, Malaysia.
  • Nurhusna Samsudin International Institute for Halal Research and Training (INHART), Level 3, Block A, KICT Building, International Islamic University Malaysia (IIUM), 53100, Selangor, Malaysia.
  • Mohammad Aizat Jamaludin International Institute for Halal Research and Training (INHART), Level 3, Block A, KICT Building, International Islamic University Malaysia (IIUM), 53100, Selangor, Malaysia.
  • Mohd Hafidz Mahamad Maifiah International Institute for Halal Research and Training (INHART), Level 3, Block A, KICT Building, International Islamic University Malaysia (IIUM), 53100, Selangor, Malaysia.

DOI:

https://doi.org/10.31436/hs.v6i2.161

Keywords:

Quality-by-Design (QbD), Halal assurance, Biopharmaceuticals, Pharmaceutical development, Conceptual framework, Pharmaceutical quality system

Abstract

 

 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. 

Author Biographies

Yumi Zuhanis Has-Yun Hashim, International Institute for Halal Research and Training (INHART), Level 3, Block A, KICT Building, International Islamic University Malaysia (IIUM), 53100, Selangor, Malaysia.

Prof. Dr. Yumi is a Professor at the International Institute for Halal Research and Training (INHART). She graduated with a degree in Biomedical Science (Hons.) from Universiti Kebangsaan Malaysia in 1999 and earned an M.Eng. in Bioprocess from Universiti Teknologi Malaysia in 2002. She worked as a Research Officer at the Chemical Engineering Pilot Plant (now the Institute of Bioproduct Development), Universiti Teknologi Malaysia, before joining academia. She then obtained her PhD from the Faculty of Life and Health Sciences, University of Ulster, UK, and served as a Postdoctoral Research Fellow at the Institute of Food and Health, University College Dublin, from February 2007 to December 2008. Dr. Yumi is an active researcher in natural products, focusing on their health benefits and halal living. She has a particular interest in agarwood, halal science, and halal studies. Currently, she is exploring the potential of natural products, traditional medicine, and halal living, and how these elements intersect to promote and maintain holistic health and well-being for people and the environment. She has received grants from government agencies and industries, published more than 40 journal articles and several book chapters, and presented her research at various local and international conferences.

Phirdaous Bin Abbas, International Institute for Halal Research and Training (INHART), Level 3, Block A, KICT Building, International Islamic University Malaysia (IIUM), 53100, Selangor, Malaysia.

Dr. Phirdaous Abbas is a Postdoctoral Research Fellow at the International Institute for Halal Research and Training (INHART), International Islamic University Malaysia (IIUM). He received his Ph.D. in Engineering from IIUM. His research focuses on halal pharmaceutical sciences, biopharmaceutical development, pharmaceutical quality systems, Quality-by-Design (QbD), natural bioactive products, and translational biotechnology. His recent work includes halal pharmaceutical innovation, the integration of halal assurance into science- and risk-based pharmaceutical development, and the bioprospecting of agarwood for the development of halalan toyyiban products and services. He has authored publications in halal pharmaceuticals, pharmaceutical biotechnology, natural products, and biomedical sciences, with a particular interest in advancing innovative and sustainable halal healthcare solutions.

Nurhusna Samsudin, International Institute for Halal Research and Training (INHART), Level 3, Block A, KICT Building, International Islamic University Malaysia (IIUM), 53100, Selangor, Malaysia.

Dr. Nurhusna Samsudin graduated with a B. Eng in Biochemical-Biotechnology (Honors) and a second degree in Business Administration from the International Islamic University Malaysia (IIUM) in 2008. She later obtained her M.Sc. and PhD in Engineering from the Biotechnology Department at IIUM, Malaysia, between 2011 and 2017. In 2018, she joined the International Institute for Halal Research and Training (INHART), IIUM, as a research fellow for two years. Since July 2020, she has been working as an assistant professor at INHART. Dr. Nurhusna is an active researcher in biomaterials, enzyme and molecular modeling, and the health benefits of phytochemical compounds, particularly from agarwood, as an alternative ingredient for halal biopharmaceutical products. She has received a national grant for a project to unravel the prescriptions in Malay medical manuscripts that use agarwood as one of the elements.

Mohammad Aizat Jamaludin, International Institute for Halal Research and Training (INHART), Level 3, Block A, KICT Building, International Islamic University Malaysia (IIUM), 53100, Selangor, Malaysia.

Dr. Mohammad Aizat Jamaludin is currently Associate Professor for International Institute for Halal Research and Training (INHART), International Islamic University Malaysia (IIUM). He graduated first and second degree from University Malaya, Malaysia in Fiqh and Jurisprudence and completed his PhD from Halal Products Research Institute (HPRI), Universiti Putra Malaysia in Shariah and Halal Laws. He was appointed as Trainer & Shariah Auditor at Halal Industry Development Corporation (HDC) from 2009 until 2011. He has extensive experience across various halal industries, with a focus on Shariah-related issues in the Halal Industry, the Muslim Friendly Tourism industry ecosystem, Malaysian Halal certification requirements, halal auditing and halal consultancy. Dr. Mohammad Aizat was specializing to Halal Audit and Certification, Muslim Friendly Tourism Ecosystem Industry includes Geopark Tourism, Muslim Friendly Spa, Shariah Compliance Services in Hospital, Railway, Airlines, Transportation, Fundamental and Determination of Halal Haram Products, Integration Fiqh and Science, Islamic and Halal Cleansing (sertu), Fiqh Consumerism, Fiqh al-Istihalah, Al-Jallalah, Al-Istitobah, Al-‘Uruf, Halal Food Culture, Halal Training and Halal Module Development. He had conducted many researches and does a presentation in conference locally and internationally on halal and its related matters. He also in charge for Halal certification body in Taiwan, Korea and China. Now, he was advisors for several Halal Industry players and Muslim Friendly Tourism and Hospitality.

Mohd Hafidz Mahamad Maifiah, International Institute for Halal Research and Training (INHART), Level 3, Block A, KICT Building, International Islamic University Malaysia (IIUM), 53100, Selangor, Malaysia.

Dr. Mohd Hafidz Mahamad Maifiah graduated in Bachelor of Biomedical Science (Hons) and Master of Science (Biotechnology Engineering) from the International Islamic University Malaysia (IIUM). He then completed his PhD in Pharmaceutical Science from the Monash Institute of Pharmaceutical Science (MIPS), Australia in 2017. His PhD thesis elucidated the mechanisms of actions of polymyxins mono- and combination therapy against multidrug-resistant Gram-negative bacteria Acinetobacter baumannii and Pseudomonas aeruginosa adopted metabolomics and transcriptomics approaches. Currently, Dr. Mohd Hafidz is an academic staff at the International Institute for Halal Research and Training (INHART), IIUM serves as the Head of Postgraduate Management. His research interests cover the areas of halal food and pharmaceutical, plant natural products for bioactive compounds, bacterial resistance, metabolomics, halal supply chain and cold chain management.   

Downloads

Published

2026-07-31

How to Cite

Yumi Zuhanis Has-Yun Hashim, Phirdaous Bin Abbas, Nurhusna Samsudin, Mohammad Aizat Jamaludin, & Mohd Hafidz Mahamad Maifiah. (2026). Operationalizing halal assurance within the quality-by-design pharmaceutical development lifecycle: A conceptual framework for biopharmaceutical development. Halalsphere, 6(2), 96–101. https://doi.org/10.31436/hs.v6i2.161

Issue

Vol. 6 No. 2 (2026): Halalsphere

Section

Short Communications

License

Copyright (c) 2026 IIUM Press

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Most read articles by the same author(s)