This chapter is a detailed account of various factors pertinent to the development and launch of a product. It begins by describing the five phases in the product launch process, namely product design and development, process design and development, product and process validation, product launch, and continuous improvement. This is followed by sections covering product-process flow diagrams and also the process elements considered for process failure mode and effects analysis. Some of the aspects covered by the engineering specifications to meet the product performance requirements are then reviewed. Details on product validation requirements and definitions of parameters related to...