Handling of GCP inspection by FDA and comparison with GCP inspection by EMA

Shigeki Nishihara, Satoshi Kuroda, Kumiko Ueda, Yu Hitobe, Akihito Higashikage, Toshimitsu Konuma, Kaori Yukiyoshi, Hiroto Okuda, Yuta Tanaka, Yoshihisa Kitamura, Koji Abe, Toshiaki Sendo

Research output: Contribution to journalArticlepeer-review

Abstract

We report our experience with GCP inspection by FDA. Prior to the inspection, preparations were made by conducting a preliminary consultation with the client and a mock inspection. The inspection by FDA was conducted by one inspector for a duration of 8 days. The inspection revealed no problem. Compared with the GCP inspection by EMA that we received previously, the GCP inspection by FDA involved the same procedures of confirming the documents related to the clinical trial, including all the primary outcomes and adverse events. The two inspections differed in the number of inspectors and the inspection schedule. Based on the experience with the FDA and EMA inspections, construction of quality control system in medical institutions is considered necessary.

Original languageEnglish
Pages (from-to)231-235
Number of pages5
JournalJapanese Journal of Clinical Pharmacology and Therapeutics
Volume49
Issue number6
DOIs
Publication statusPublished - 2018

Keywords

  • EMA
  • FDA
  • GCP
  • Inspection

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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