Quality by Design (QbD) in Pharmaceutical Manufacturing

Quality by Design (QbD) in Pharmaceutical Manufacturing

Introduction

If, in certain countries, total quality seems to have become outdated, this is not the case in Europe where the movement is being reinforced and developed in many branches of industry. The terminology may have evolved but the spirit of process improvement and quality management is increasingly present.

For a long time reserved to the largest companies, the tidal wave of quality management reaches today many SME and even public sector organisations. As for the branches of industry concerned, they also diversify, as industries traditionally centered on “product quality” (such as the pharmaceutical sector) are starting to reconfigure their processes and to develop managerial strategies leaning toward “organisational excellence”. One of the key factors of this development seems to be the ever increasing link between quality and strategy both in academic works and in professional practices.

Strategy and quality: which correlations?

In the traditional concepts of strategy and quality (those of the 1960s and 1970s in particular) the relations between these two concepts are not strong:

1. (1) On the one side, strategy is traditionally conceived as the choice of an external positioning (in terms of products on the markets). It is the case of the oldest trends (as in Harvard's “business policy” approach, Ansoff's “corporate strategy”, or even the methods of competitive strategy of the large consulting firms such as BCG, McKinsey and ADL; but this exteriorized representation of the strategy can also be found in the works of more recent theorists such as Porter (1980).

2. (2) On the other side, quality refers to the product, apprehended accordingly primarily to technical procedures and standards. Thus, complex statistical tools have first been developed to control the product conformity; then the logic of quality assurance leads to the set-up of procedures and specifications to guarantee the obtaining of a certain level of quality and to allow the “certification” of the firm as viewed by its external partners (Couret et al., 1995).

In this conception, quality is first of all the business of production and of internal logisticians, but is not usually positioned on a more global level. Indeed, the kind of quality sought for might correspond to a brand level which represents the adopted strategic positioning, but the relation “strategy-quality” usually stops there.

Today's concepts are completely different, at least in some professional environments. Also, the current tendencies lead to a necessary complementarity between total quality (or “global”) and strategic management (Hermel, 1989). Indeed if strategy is defined as all alternatives leading to aim at a determined direction in the mid-to-long term for all activities and operations of the organization (Martinet, 1984), it assumes the orchestration of all entrepreneurial resources to create competitive advantages and a potential for evolution.

Quality by Design (QbD) in Pharmaceutical Manufacturing

The organisational processes, their effectiveness and their fluidity, their impacts in terms of innovation, and their direct and indirect costs constitute first order strategic factors, which carry logic of quality and excellence at all stages of the firm's ...