Good clinical practice (GCP) inspection procedures
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in the context of the centralised procedure.
These inspections are adopted by the CHMP and may be routine or may be triggered by issues arising during the assessment of the dossier or by other information such as previous inspection experience.
They are usually requested during the initial review of a marketing authorisation application, but could arise post-authorisation (e.g. inspection of studies conducted or completed as part of the condition of a marketing authorisation, or because of concerns arising about the studies previously submitted).
Guidance is available for inspectors on how to initiate and conduct remote inspections to verify compliance with GCP standards during the COVID-19 pandemic:
The guidance covers all phases of remote GCP inspections, with a particular focus on the more challenging aspects, such as inspection initiation, feasibility assessment and preparation.
EMA published the guidance on 10 June 2020.
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Guidance on remote GCP inspections during the COVID-19 pandemic (PDF/275.49 KB)
Adopted
First published: 10/06/2020
EMA/INS/GCP/162006/2020 -
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Guidance on triggers for inspections of bioequivalence trials: quick scan (PDF/121.5 KB)
Adopted
First published: 20/08/2013
Last updated: 02/03/2017
Legal effective date: 01/03/2017
EMA/745861/2016 -
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Reflection paper on advice to applicants/sponsors/CROS of bioequivalence studies (PDF/103.63 KB)
Adopted
First published: 19/09/2008
Last updated: 19/09/2008
EMEA/INS/GCP/468975/2007 -
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INS-GCP-1 procedure for coordinating good-clinical-practice inspections requested by the CHMP (PDF/348.07 KB)
Adopted
First published: 21/02/2008
Last updated: 23/05/2014
EMEA/INS/GCP/197225/2005 -
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INS-GCP-2 procedure for preparing GCP inspections requested by the EMEA (PDF/99.01 KB)
Adopted
First published: 20/09/2007
Last updated: 20/09/2007
EMEA/INS/GCP/197228/2005 -
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INS-GCP-3 procedure for conducting GCP inspections requested by the EMEA (PDF/29.07 KB)
Adopted
First published: 20/09/2007
Last updated: 20/09/2007
EMEA/INS/GCP/197223/2005 -
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Annex I to procedure for conducting GCP inspections requested by the CHMP: Investigator site (PDF/232 KB)
Adopted
First published: 20/09/2007
Last updated: 05/05/2022
EMA/INS/GCP/143492/2022 -
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Annex II to procedure for conducting GCP inspections requested by the CHMP: Clinical laboratories (PDF/281.83 KB)
Adopted
First published: 20/09/2007
Last updated: 05/05/2022
EMA/INS/GCP/154768/2022 -
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Annex III to procedure for conducting good-clinical-practice inspections requested by the EMA: Computer systems (PDF/180.09 KB) (updated)
Adopted
First published: 28/11/2007
Last updated: 22/09/2023
EMA/INS/GCP/155774/2022 -
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Annex IV to procedure for conducting GCP inspections requested by the CHMP: Sponsor and Contract Research Organisations (CRO) (PDF/292.79 KB)
Adopted
First published: 20/09/2007
Last updated: 05/05/2022
EMA/INS/GCP/155794/2022 -
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Annex V to procedure for conducting GCP inspections requested by the EMEA: Phase I units (PDF/234.26 KB) (updated)
Adopted
First published: 23/07/2008
Last updated: 22/09/2023
EMA/INS/GCP/416131/2023 -
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Annex VI to procedure for conducting GCP inspections requested by the CHMP: Record keeping and archiving of documents (PDF/243.83 KB)
Adopted
First published: 20/09/2007
Last updated: 05/05/2022
EMA/INS/GCP/183077/2022 -
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Annex VII to procedure for conducting GCP inspections requested by the CHMP: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials (PDF/230.63 KB)
Adopted
First published: 28/05/2008
Last updated: 05/05/2022
EMA/INS/GCP/188326/2022 -
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INS-GCP-4 procedure for reporting of good-clinical-practice inspections requested by the CHMP (PDF/239.56 KB)
Adopted
First published: 20/09/2007
Last updated: 15/05/2017
EMA/INS/GCP/158549/2016 Rev.1 -
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Appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report (PDF/367.44 KB)
First published: 29/07/2013
Last updated: 13/07/2022 -
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Appendix 2 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP integrated inspection report (PDF/268.25 KB)
First published: 29/07/2013
Last updated: 15/05/2017 -
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Principal documents taken into account for the preparation of procedures for GCP inspections requested by the CHMP (PDF/118.91 KB)
First published: 20/09/2007
Last updated: 18/02/2022
EMA/30963/2022 -
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Standard operating procedure for co-ordination of GCP inspections (PDF/145 KB)
Adopted
First published: 16/05/2007
Last updated: 27/09/2012
Legal effective date: 27/09/2012
SOP/INSP/2020