Abstract
Pharmaceutical Industry in Japan has made an fairly advancement since 1980s. In the course of the advancement, GMP played an important role, which has close relations with the development particularly, in CMC (Chemistry and Managing Control) and pre-approval inspection. In this paper, relationship between GMP and the development of pharmaceuticals has been discussed through the author's experiences. In 1980s, Takeda developed three kinds of Cephem-antibiotics in Japan, however, failed to launch them in USA due to the delay of their development. The delay was partly caused by GMP and regulatory procedures to FDA. In the next decade, Takeda has made a great success in developing LUPRON DEPOT, a drug of prostatic cancer and other new pharmaceuticals. These successes have been attributed to the well designed manufacturing process based on GMP. The complex aseptic processes have been designed and validated based on the current GMP. As the next new product, Aripiprazole (ABILIFYTM), a drug for schizophrenia, developed by Otsuka was successfully launched in USA by use of an alternative facility located in Japan, which was approved by FDA. The facility took a place of a problematic facility located in other country. Both of the products became blockbuster products in 2000s. Next to these successes, bio-product, which is now under development has encountered with several problems to overcome. Some of them are GMP and how to keep consistency from the initial stage of development to the stage of industrial production. These would be overcome in near future by taking GMP and consistency into account.
