Abstract
The pharmaceutical quality and related matters by outsourcing in pharmaceutical development are described from a viewpoint of contract giver based on the recent development trend of Japanese pharmaceutical companies. The quality risk management by a contract giver should be conducted as the product lifecycle for outsourcing in pharmaceutical development. Although speed and technology are primarily requisites for the development, the quality agreement for confidentiality and patent rights should be also required. The global GMP should be conformed for the manufacturing of investigational medicinal products. Change control and technology transfer in the development process should be justified the consistency of products. The NDA by a contract giver should be consistent with information through the development process and compiled as a result.
