Japanese authority GLP inspections for pharmaceuticals and agrochemicals. Preparing for and handling agency inspections.

This presentation covers the essentials of recent Good Laboratory Practice (GLP) inspections conducted in Japan, after applications have been made for new ethical drugs to be authorized by the Ministry of Health and Welfare (MHW) or for agricultural chemicals by the Ministry of Agriculture, Forestry, and Fishery. Recently, the functions of MHW/GLP inspections were, for the most part, transferred from MHW to "The Organization for Drug ADR Relief, R&D Promotion and Product Review" ("Drug Organization," in short). This organization is now responsible for the audit and facility inspections for GLP compliance, both for new drug applications and for animal safety tests conducted at contract laboratories. The methods of inspection are expected to be the same as those used by MHW. A recent inspection audited by the Ministry of Agriculture, Forestry, and Fisheries is also reviewed here, for comparison.