Approach to the Integration of Management Systems in a Pharmaceutical Organization

Abstract

This paper discusses how a system approach to management can be used for the development and implementation of an integrated management system (IMS) in a company producing medicinal products. It is argued in the paper that approaches to the solutions of how to integrate management systems all require two elements: a conceptual model and a supporting methodology. Although a large number of models has been developed that could provide the basis for integration, development of methodologies to achieve fully integrated systems is still stagnating. This paper presents the IMS model that can be used to integrate the requirements of existing and upcoming standards in the pharmaceutical industry, followed by a discussion on the issue of the IMS methodology.