Education and training for GMP inspectors in Japan to ensure international harmonization of GMP inspection

Abstract

In March 2012, Japan has applied for entry into the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperation Scheme (PIC/S), a framework for legally non-binding and informal cooperation among Good Manufacturing Practice (GMP) inspection authorities; further, it was approved as the 45th member in May 2014. Ensuring the quality of each GMP inspector was a challenge for Japan’s accession to the PIC/S. In response, the education and training programs were strengthened by the expansion of joint GMP mock inspections. In addition, the guidelines for GMP inspection have been revised to define requirements for the inspectors, and stipulate that completion of the training course conducted by the National Institute of Public Health is equivalent to one year of work experience related to GMP. This training course aims to foster inspectors who is capable of performing a GMP inspection at an international level, and has played an important role in the education and training of GMP inspectors since its inception in fiscal year 1987. This article outlines the education and training programs provided for the GMP inspectors in Japan and training course conducted by NIPH to secure quality of pharmaceuticals and medical devices.