APIC Third Party Audit at Boehringer Ingelheim, Germany


On 4 and 5 May 2022 a regular re-Audit at Boehringer Ingelheim’s API manufacturing site in Ingelheim, Germany, was performed. A re-Audit is recommended every 2-3 years in order to check the facility for on-going GMP compliance. One certified APIC Auditor performed the Audit during the course of two days.

This re-Audit was initiated by customers of Boehringer. 

The audit report contains a detailed description of the findings and is structured as follows:

  • General information about the APIC Audit Programme
  • General information about the Audit Report
  • Management summary with:
    • Purpose of the Audit
    • Conclusions
    • Acknowledgements
  • General information about the auditee
  • Detailed description of the auditee’s
    • Organisation and personnel
    • Quality Systems
    • Facilities
    • Equipment
    • Computerised Systems
    • Material Systems/Supplier Qualification
    • Production
    • Packaging and Labeling
    • Laboratories
  • Auditors’ observations with a classification of each observation

The following products were covered during the Audit:

  • Olodaterol API
  • Epinastinhydrochlorid API
  • Butylscopolaminiumbromid API

Due to the structure of the APIC Audit Programme, the audit report is copyrighted by the parties involved. The API Compliance Institute controls the publication of the report and assures that the copyright of the customers and of Boehringer Ingelheim will be respected. The report can be purchased from the ACI only with the prior approval of Boehringer Ingelheim.

If you are interested in the Audit Report please contact the API Compliance Institute at: