Akademska digitalna zbirka SLovenije - logo
E-viri
Celotno besedilo
Odprti dostop
  • Consideration of online GMP...
    MIZUSHIMA, Hiroshi; TERADA, Hiroshi; TAKUMOTO, Yuki; YAMAGUCHI, Ichiro

    Journal of the National Institute of Public Health, 2022/10/31, Letnik: 71, Številka: 4
    Journal Article

    Every year, the National Institute of Public Health (NIPH) conducts "Pharmaceutical Hygiene Management Training" as training course for pharmaceutical inspectors belonging to 47 prefectures and PMDA to carry out GMP inspections. In this training, which is held every year for 5 weeks, in addition to the classroom training, mock inspections are conducted with the cooperation of the pharmaceutical plants. In the fiscal year 2021, we gathered online in May 2021 for classroom lectures (3 weeks), preparations for mock inspections and on-site inspections (1 week), and then compiled the report. At that time, we examined whether online inspection could be done. With the cooperation of the pharmaceutical plants, an online inspection was also conducted in hybrid style among three training teams.As a result of conducting a hybrid style mock inspection exercise with 5 participants in the field and 7 participants online, we convinced the possibility of online inspection as an efficient inspection method by making improvements, although there are various restrictions.We hope that this experience will lead to the possibility of online inspections in the future, and we report this time.