Report of Discussion Related to GMP Inspection Based on the Results of the Survey “The Questionnaire Survey on Actual Situation of Established Conditions, Regulatory Actions Required for Changes and GMP inspection”

Abstract

 The Japan Pharmaceutical Manufacturers Association’s Regulatory Affairs Committee conducted the first survey about the actual situation of quality related Established Conditions, the submission category for changes, review periods and GMP inspection in Japan, US and EU in 2022 and reported differences in Japan, US and EU. We conducted the second survey to seek the cause of the differences in Japan, US and EU based on the result of the first survey and report differences in GMP inspection in Japan, US and EU.