Glossary:TAG-00044-Ins-ion

Glossary > Inspection

Inspection
Tag-ID	TAG-00044-Ins-ion
English	Inspection / GCP inspection / Regulatory inspection
French	Inspection / Inspection des bonnes pratiques cliniques / Inspection réglementaire
German	Inspektion / GCP-Inspektion / Behördliche Inspektion

References

	Scope	Document part	Language	Document
AUT BASG - FAQ 11-Feb-2025 Schwarz	G	Schwarz	DE	AUT BASG - FAQ 11-Feb-2025
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42c	HM	§ 42c	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 68	MD	§ 68	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 77	MD	§ 77	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 79	MD	§ 79	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3	G	4.3	EN	EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023
EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 5	G	5	EN	EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6	MD	ANNEX XV Chapter III, 6	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 5	MD	Article 72 Pragraph 5	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 5	IVD	Article 68 Paragraph 5	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 78	HM	Article 78	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (l)	HM	Article 2 (l)	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 -	HM	-	EN	GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015
GBR MHRA GCP Inspection Dossier template V7.0 -	G	-	EN	GBR MHRA GCP Inspection Dossier template V7.0
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Inspection	G	GLOSSARY - Inspection	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities	G	GLOSSARY - Regulatory Authorities	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.11	MD	7.11	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.58	HM	§ 312.58	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.68	HM	§ 312.68	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.145	MD	§ 812.145	EN	USA 21 CFR Part 812 09-Apr-2025
USA FDA Information - Observations and citations 20-Mar-2024 -	G	-	EN	USA FDA Information - Observations and citations 20-Mar-2024
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11.2	HM	11.2	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002	HM	4.12	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-003	HM	4.12	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection	HM	Glossary - inspection	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995