The application of total quality principles to the South African pharmaceutical industry

Abstract

The traditional quality culture in the pharmaceutical industry is driven by the regulatory process of marketing authorisation and manufacturing authorisation. These components of the South African regulatory control system are exclusively technically-orientated, with no managerial focus. This study identifies several quality management principles which could find general application in the pharmaceutical industry. The research compares the current regulatory control system with the total quality concept, and highlights the positive contribution which the total quality approach is able to make in terms of its field of reference; the strategic business value of quality; quality policy formulation; the quality organisational structure; enhanced operations management; and management's control over quality costs, in particular