These procedures have been developed and evaluated in practice by the GCP Inspectors Working Group and are now published for the first time. They will be revised and updated, as necessary, in the light of experience.

The following procedures are available:

-- INS-GCP-1 Procedure for coordinating GCP inspections requested by the EMEA;

-- INS-GCP-2 Procedure for preparing GCP inspections requested by the EMEA;

-- INS-GCP-3 Procedure for conducting GCP inspections requested by the EMEA;
- Annex I: Investigator Site,
- Annex II: Clinical Laboratories,
- Annex III: Computerised Systems,
- Annex IV: Sponsor and CRO,
- Annex V: Phase I Units,
- Annex VI: File structure and archiving,

-- INS-GCP-4 Procedure for reporting of GCP inspections requested by the EMEA;

The EMEA published also a list of principal Documents taken into account for the preparation of these procedures.

Links:
GCP Inspection procedures