Inspections

Inspections are an official task carried out by the Paul-Ehrlich-Institut (PEI) and are used to verify actual conditions on-site, e.g. at pharmaceutical companies, sponsors and service providers, as well as in laboratories and test centres.

The Paul-Ehrlich-Institut carries out inspections worldwide:

• to verify compliance with good clinical practice (GCP) in national clinical trial approval procedures or within the framework of national or centralised European marketing authorisation procedures (GCP inspections),
• within the European Plasma Master File (PMF) certification procedure for verifying information related to human plasma as a starting material for manufacturing of medicinal products (PMF inspections),
• to evaluate medicinal product safety systems (human and veterinary pharmacovigilance, tissue vigilance, haemovigilance, and inspections) at the national and European level,
• within the national marketing authorisation procedure to verify submitted data.

In addition, experts from the Paul-Ehrlich-Institut accompany inspections conducted by the competent federal state authorities in the course of issuing authorisations and certificates as well as in routine monitoring.

The Paul-Ehrlich-Institut staff and the federal state authority staff cooperate closely during these inspections.

Contact

Inspections of Biomedicines Section
Email: inspektionen@pei.de

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