Reference: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: Difference between revisions
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | EU INS/GCP/46309/2012
- Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 |
| Validity area | EU |
| Scope(s) | G |
| Document name | INS/GCP/46309/2012
- Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP |
| Version / Revision | 2012 |
| Status | Current |
| Document type | Information from official body |
| Language(s) | EN |
| Description | INS/GCP/46309/2012
Compliance and Inspections Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP (Inspection reports to EMA 2000-2012) |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 — Unit 4.5.2 |
| Scope | G |
| Document part | 5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Inspection, Good clinical practice, EMA |
| Comment | Overview of GCP inspections by CHMP |
Content
5. Results
5.1. Overview of GCP inspections requested by the CHMP and carried out between 2000-2012
Between 2000-2012, a total of 398 site inspections were carried out. The distribution of the number of inspections classified as routine and triggered is shown in figure 1. It can be seen that the number of inspections has increased since 2006 mainly, due to routine inspections in line with the implementation of the GCP Inspection policy in 2006. [...]
