Category: Review Article
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Author byline as per print journal: Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri3; Noor Fadzilah Zulkifli1; Mohd Mahyeddin Mohd Salleh3; Nazariyah Yahaya4; Khairun Nain Nor Aripin1; Shahirah Nadiah Shaharuddin5; Seri Azalina Mohd Ghazalli6; Muhammad Syazan Sulaiman6

Abstract:
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 certification. 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.

Submitted: 4 April 2023; Revised: 22 August 2023; Accepted: 23 August 2023; Published online first: 5 September 2023

Implementation of Halal Management System (HMS) in the manufacturing of solid oral dosage forms

Halal is an integral observance for all Muslims. This concept originates from an Arabic word and can be defined as permissible by shariah law. The consumption of halal foods is mandated under Islamic teachings and includes, water and beverages, meals and snacks, as well as pharmaceutical medicines. Medicines also fall under Islamic dietary law and are required to be halal and Muslims are forbidden to use illicit drugs except in an emergency [1].

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.