The proceedings in the authorisation procedure for studies and in the registration procedure for a marketing authorisation are quite complex, and GCP auditors will wonder how audits can be conducted effectively at testing sites and CROs. For their purposes, the various supervisory authorities have created and published documents for their inspectors, which also give valuable advice to the GCP auditors of the sponsor. On the other hand, they help preparing also for beiing audited or inspected.
The following examples can be given:
EMEA Inspection procedures and guidances for GCP inspections in the context of the centralised procedure: These were developed by the GCP Inspectors Working Group and describe co-ordination, preparation, conduct and reporting of GCP inspections.
The ZLG (central authority of the German federal states for health protection) has created a standard operating procedure on inspection procedures for clinical trials for medicinal products that are subject to approval. The annexed detailed check lists are also quite interesting.
As for the FDA, one can find Compliance Program Guidance Manuals within the Bioresearch Monitoring Program (BIMO).
The described inspections can be conducted at testing sites, CROs, central laboratories and the sponsors.
On behalf of the European Compliance Academy (ECA)