Ka-Liong TanAinoon OthmanIrwan Mohd SubrNoor Fadzilah Zulkifl iMohd Mahyeddin Mohd SallehNazariyah YahayaKhairun Nain Nor AripinShahirah Nadiah ShaharuddinSeri Azalina Mohd GhazalliMuhammad Syazan Sulaiman2024-06-162024-06-1620232024-1-23Tan Ka Liong,Ainoon Othman ; Irwan Mohd Subri ; Noor Fadzilah Zulkifl i ; Mohd Mahyeddin Mohd Salleh ; Nazariyah Yahaya ; Khairun Nain Nor Aripin ; Shahirah Nadiah Shaharuddin ; Seri Azalina Mohd Ghazalli ; Muhammad Syazan Sulaiman (2023). The incorporation of the Halal Management System (HMS) by the pharmaceutical industry. Generics and Biosimilars Initiative Journal, 12(3), 87–94. https://doi.org/10.5639/gabij.2023.1203.0142033-6772873-3210.5639/gabij.2023.1203.014https://oarep.usim.edu.my/handle/123456789/20180https://gabi-journal.net/the-incorporation-of-the-halal-management-system-hms-by-the-pharmaceutical-industry.htmlGenerics and Biosimilars Initiative Journal, Volume 12 Issue 3 Page (87–94)In recent years there has been a rapid growth of the halal pharmaceutical industry, especially in the supply chain of solid oral dosage forms of medication. This article outlines aspects of the Halal Management System (HMS) in the development and production of halal pharmaceuticals. It explains the needs and requirements of HMS and identifies the challenges faced in implementation. The article outlines aspects of executions and hurdles encountered when standardizing halal certifi cation. The article also highlights the need for systematic traceability systems and effective product recall mechanisms to ensure adherence to halal requirements. It also highlights the grey areas for halal in terms of pharmaceutical manufacture that are brought about by use of non-halal raw materials, e.g. alcohol, gelatine, glycerin, lecithin, glutamic acid and stearates.en-US: Halal assurancehalal pharmaceuticalshalal managementoral dosagesupply chaintext::journal::journal article19123