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 journalArticle

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 - Jan 1 2018

Fingerprint

Quality Control
Appointments and Schedules
Referral and Consultation
Clinical Trials

Keywords

  • EMA
  • FDA
  • GCP
  • Inspection

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Handling of GCP inspection by FDA and comparison with GCP inspection by EMA. / Nishihara, Shigeki; Kuroda, Satoshi; Ueda, Kumiko; Hitobe, Yu; Higashikage, Akihito; Konuma, Toshimitsu; Yukiyoshi, Kaori; Okuda, Hiroto; Tanaka, Yuta; Kitamura, Yoshihisa; Abe, Koji; Sendo, Toshiaki.

In: Japanese Journal of Clinical Pharmacology and Therapeutics, Vol. 49, No. 6, 01.01.2018, p. 231-235.

Research output: Contribution to journalArticle

Nishihara, S, Kuroda, S, Ueda, K, Hitobe, Y, Higashikage, A, Konuma, T, Yukiyoshi, K, Okuda, H, Tanaka, Y, Kitamura, Y, Abe, K & Sendo, T 2018, 'Handling of GCP inspection by FDA and comparison with GCP inspection by EMA', Japanese Journal of Clinical Pharmacology and Therapeutics, vol. 49, no. 6, pp. 231-235. https://doi.org/10.3999/jscpt.49.231
Nishihara, Shigeki ; Kuroda, Satoshi ; Ueda, Kumiko ; Hitobe, Yu ; Higashikage, Akihito ; Konuma, Toshimitsu ; Yukiyoshi, Kaori ; Okuda, Hiroto ; Tanaka, Yuta ; Kitamura, Yoshihisa ; Abe, Koji ; Sendo, Toshiaki. / Handling of GCP inspection by FDA and comparison with GCP inspection by EMA. In: Japanese Journal of Clinical Pharmacology and Therapeutics. 2018 ; Vol. 49, No. 6. pp. 231-235.
@article{54b0daf74d75460690fc846a372a2914,
title = "Handling of GCP inspection by FDA and comparison with GCP inspection by EMA",
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.",
keywords = "EMA, FDA, GCP, Inspection",
author = "Shigeki Nishihara and Satoshi Kuroda and Kumiko Ueda and Yu Hitobe and Akihito Higashikage and Toshimitsu Konuma and Kaori Yukiyoshi and Hiroto Okuda and Yuta Tanaka and Yoshihisa Kitamura and Koji Abe and Toshiaki Sendo",
year = "2018",
month = "1",
day = "1",
doi = "10.3999/jscpt.49.231",
language = "English",
volume = "49",
pages = "231--235",
journal = "Japanese Journal of Clinical Pharmacology and Therapeutics",
issn = "0388-1601",
publisher = "Japanese Society of Clinical Pharmacology and Therapeutics",
number = "6",

}

TY - JOUR

T1 - Handling of GCP inspection by FDA and comparison with GCP inspection by EMA

AU - Nishihara, Shigeki

AU - Kuroda, Satoshi

AU - Ueda, Kumiko

AU - Hitobe, Yu

AU - Higashikage, Akihito

AU - Konuma, Toshimitsu

AU - Yukiyoshi, Kaori

AU - Okuda, Hiroto

AU - Tanaka, Yuta

AU - Kitamura, Yoshihisa

AU - Abe, Koji

AU - Sendo, Toshiaki

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - EMA

KW - FDA

KW - GCP

KW - Inspection

UR - http://www.scopus.com/inward/record.url?scp=85058792827&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85058792827&partnerID=8YFLogxK

U2 - 10.3999/jscpt.49.231

DO - 10.3999/jscpt.49.231

M3 - Article

AN - SCOPUS:85058792827

VL - 49

SP - 231

EP - 235

JO - Japanese Journal of Clinical Pharmacology and Therapeutics

JF - Japanese Journal of Clinical Pharmacology and Therapeutics

SN - 0388-1601

IS - 6

ER -