The Paul-Ehrlich-Institut is responsible for the performance of onsite inspections at e.g. pharmaceutical companies, investigator and sponsors sites, laboratories and service providers.
The PEI conducts worldwide inspections
- to verify compliance with Good Clinical Practices (GCP) in connection with national clinical trial authorizations and national or European marketing authorizations (GCP-inspections)
- in the scope of the European Plasma Master File Certification Procedure (PMF-inspections)
- of pharmacovigilance systems (for human and veterinary medicinal products, haemovigilance and the vigilance of tissues and cells) (PhV-inspections)
- within the national marketing authorization procedure in order to verify the data submitted.
In addition, experts of the PEI accompany inspections of the competent authorities of the federal states for the issuance of authorizations and certificates.
For all types of inspections, the employees of the PEI collaborate closely with those of the competent authorities of the federal states.
Section Inspections of Biomedicines