Variability is more than just the ‘noise in the system.’ It represents
an insidious threat to companies, ranging from the reliability of their product
lines to the strength of their financial bottom-lines. The understanding of
variability sources, therefore, can provide a solid framework for risk assessment
and an estimation of the impact these risks pose.
This book examines those elements of variability as they relate to people,
processes, manufacturing systems, non-manufacturing systems, quality systems,
laboratory systems, supply chains and GMP codes related to the pharmaceutical
industry. It provides a new perspective on the meaning and relationship of variability
in relation to work performed, as well as an insightful framework for the quality
assessment of risk in the pharmaceutical industry.