Computerised systems framework for the halal pharmaceuticals
by Mohd Khanapi Abd Ghani; Raja Rina Raja Ikram; Abd Samad Hasan Basari
International Journal of Telemedicine and Clinical Practices (IJTMCP), Vol. 1, No. 1, 2015

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.

Online publication date: Mon, 18-May-2015

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