THE SOURCES OF QUALITY IN THE PHARMACEUTICAL INDUSTRY
Enrique A. Yacuzzi (Universidad del CEMA)
Fernando Martín (Aventis Pharma)
Gabriel Vignola (Instituto Nacional de Tecnología Industrial)
Verónica Mayochi (Empresa Mayco)
Dante Tollio (Instituto Argentino de Normalización)
ABSTRACT
Quality is not created spontaneously. It is designed and manufactured: It has its own sources. A somewhat elusive concept, quality is difficult to define and easy to perceive. This combination of traits obscures the study of factors that help to discover, produce, and distribute quality products and services.
This paper analyzes the sources of quality of a pharmaceutical product. After identifying eight quality dimensions, a framework of hypothetical sources that contribute the most to shape those dimensions is established. The framework, based on Garvin’s pioneering work, is applied to case studies of laboratories operating in Argentina.