Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 a)
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| Document information | |
|---|---|
| Reference | EU EMA/INS/GCP/126568/2023
- Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/INS/GCP/126568/2023
- Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 |
| Version / Revision | 2023 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/INS/GCP/164938/2024
Inspections Office Quality and Safety of Medicines Department Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2023 Adopted by the GCP IWG on 26 November 2024 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 â Unit 4.5.2 |
| Scope | G |
| Document part | 3.1.2
a) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Inspection finding, Critical finding, Major finding, Minor finding, Inspection |
| Comment | Categorisation of inspection findings |
Content
3.1.2. Categorisation of findings a) General overview A total of 470 deficiencies, comprising 17 critical (3.6%), 260 major (55.3%) and 193 minor (41.1%) findings were recorded for the 36 CHMP requested inspections conducted in 2022. This represents an average of 13 findings per site inspected. The main findings observed in the 2022 inspections are detailed below in accordance with the GCP categorisation of findings agreed by the GCP IWG. [...]
