Documentation Protocol in Product Development Including Clinical Records

Abstract Product development involves the design of a quality product and manufacturing processes for assuring the consistent production of a required quality product. Documentation in the product development describes all the procedures and specifications related to product development. Documentation protocol provides the knowledge about the product and manufacturing processes to the reviewers and inspectors. Documentation controls or minimizes the risks, misinterpretation, and prospective errors that may occur during the process of product development. This chapter summarizes the contents that should be discussed in the documentation protocol for pharmaceutical development. This chapter also describes the guidelines that should be followed for the generation of the clinical trial data that are aimed to be submitted to regulatory authorities.