Abstract:Quality control has experienced three stages:inspection quality control, statistical quality control and total quality control. In order to achieve total quality control, Juran proposed the quality by design (QbD), which extends the concept of quality to various fields and stages of quality related activities. The content of holistic quality control of Chinese medicine and quality by design is inherently consistent, which lays a good foundation for the application of QbD in the research and development of Chinese medicine products. This paper presented and explained the two dimensions of quality control in the whole process of Chinese medicine, that was, the product life cycle dimension from R&D to commercial production and the industrial chain dimension from raw materials to final products. And this paper had also summarized the application examples of holistic process quality control of Chinese medicine in herbal planting process, the production process of Chinese medicine preparation and the circulation process of Chinese medicine products.