Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection
From GxPlex
| Document information | |
|---|---|
| Reference | WHO WHO - Guidelines for GCP for trials on
pharmaceutical products* 1995 |
| Validity area | WHO |
| Scope(s) | HM |
| Document name | WHO - Guidelines for GCP for trials on
pharmaceutical products* |
| Version / Revision | 1995 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | World Health Organization
WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products* |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 â Unit 4.5.2 |
| Scope | HM |
| Document part | Glossary - inspection |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Inspection, Definition, Good clinical practice, Audit |
| Comment | Definition of inspection (GCP context) |
Content
inspection An officially-conducted examination (i.e. review of the conduct of the trial, including quality assurance, personnel involved, any delegation of authority and audit) by relevant authorities at the site of investigation and/or at the site of the sponsor in order to verify adherence to Good Clinical Practice as set out in this document.
