Third Party Audit at Boehringer Ingelheim

According to legal regulations, market authorization holders are required to audit their API suppliers regularly. Shared third-party auditing is an option to meet these requirements. In April 2015, a third-party audit was performed, as part of the Active Pharmaceutical Ingredients Committee (APIC) Audit Programme, at Boehringer Ingelheim Germany, the company’s largest manufacturing site for active pharmaceutical ingredients (APIs).

Qualified Persons from several companies commissioned the audit. Initiation by one or more Qualified Persons is a requirement defined in the Q & A Document. The audit was performed by two certified APIC auditors. The results were summarised in an audit report, which 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
  • Auditor's observations with a classification
  • Summary of 'recommendations' for quality, safety or efficiency improvement (alphabetical numbering system).

The certified audit report is copyrighted by the parties involved who agreed to share the audit report with other companies in need of such certified documentation. The API Compliance Institute oversees the publication of the report and ensures that the copyright of its clients and of Boehringer Ingelheim are respected at all times. Consequently, the report can only be obtained from the API Compliance Institute.

Which API’s are currently covered by the Audit:

  • Atropine
  • Digoxin
  • Dihydroergotamine
  • Epinastine
  • Epinephrine
  • Etilefrine
  • Homatropine
  • Hyoscine-n-butylbromide
  • Metildigoxin
  • Homatropine
  • Phenylephrine
  • Scopolamine
  • … and the respective salts

of the above compounds

If you are interested in the Audit Report please contact the API Compliance Institute: becker@api-compliance.org