Title: Computerised systems framework for the halal pharmaceuticals

Authors: Mohd Khanapi Abd Ghani; Raja Rina Raja Ikram; Abd Samad Hasan Basari

Addresses: Biomedical Computing and Engineering Technologies (BIOCORE Malaysia) Applied Research Group, Center for Advanced Computing Technology (C-ACT), Universiti Teknikal Malaysia Melaka, Hang Tuah Jaya, 76100, Durian Tunggal, Melaka, Malaysia ' Biomedical Computing and Engineering Technologies (BIOCORE Malaysia) Applied Research Group, Center for Advanced Computing Technology (C-ACT), Universiti Teknikal Malaysia Melaka, Hang Tuah Jaya, 76100, Durian Tunggal, Melaka, Malaysia ' Biomedical Computing and Engineering Technologies (BIOCORE Malaysia) Applied Research Group, Center for Advanced Computing Technology (C-ACT), Universiti Teknikal Malaysia Melaka, Hang Tuah Jaya, 76100, Durian Tunggal, Melaka, Malaysia

Abstract: This research aims to develop a framework to address halal regulatory industry requirements for computer validation in the pharmaceutical industry. A critical analysis on the existing system was conducted in three main areas. First, an analysis of computerised systems used throughout the pharmaceutical supply chain. Second, the identification of critical points and controls required in halal pharmaceuticals based on the guidelines of two countries - Malaysia and Indonesia - and third, a review of existing regulatory requirements for computerised systems. A hazard analysis critical control point (HACCP) method was used to identify critical control points that lead to Haram contamination. These critical points were then validated via a review of a validation exercise of a manufacturing execution system (MES) implementation, a case study of computer validation exercise for an enterprise resource planning (ERP) implementation, a critical analysis of the international pharmaceutical industry standards and interview with subject matter experts.

Keywords: halal pharmaceuticals; computer validation; halal standards; halal regulations; pharmaceutical industry; pharmaceutical supply chains; Malaysia; Indonesia; computerised systems; HACCP; critical control points; Haram contamination; manufacturing execution systems; MES implementation; enterprise resource planning; ERP.

DOI: 10.1504/IJTMCP.2015.069474

International Journal of Telemedicine and Clinical Practices, 2015 Vol.1 No.1, pp.77 - 93

Received: 30 Dec 2013
Accepted: 20 Apr 2014

Published online: 18 May 2015 *

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