This book begins by making the assumption that readers either have a laboratory function within their own organization or have an external facility. It is the laboratory-based quality system that will be translated into the area of Phase 1 Good Clinical Practice (GCP). Nearly all the books I have read on quality management within the regulated environment start off with the history and origins of Good Laboratory Practice (GLP). This book makes the assertion that GLP is here and will not consider its origins at all, which hopefully will be a refreshing change for the reader.