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

doi:10.3999/jscpt.49.231

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 journal › Article › peer-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 language	English
Pages (from-to)	231-235
Number of pages	5
Journal	Japanese Journal of Clinical Pharmacology and Therapeutics
Volume	49
Issue number	6
DOIs	https://doi.org/10.3999/jscpt.49.231
Publication status	Published - 2018

Keywords

EMA
FDA
GCP
Inspection

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

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10.3999/jscpt.49.231

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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.",

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AU - Higashikage, Akihito

AU - Konuma, Toshimitsu

AU - Yukiyoshi, Kaori

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AU - Tanaka, Yuta

AU - Kitamura, Yoshihisa

AU - Abe, Koji

AU - Sendo, Toshiaki

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

Abstract

Keywords

ASJC Scopus subject areas

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