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APIC Third Party Audit at Boehringer Ingelheim, Germany

 

On 15 - 16 April 2015 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. Two certified APIC Auditors performed the Audit during the course of two days.

This re-Audit was initiated by 15 customers of Boehringer. Upon completion of the audit more than 40 pharmaceutical companies purchased the finalised report.

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

  • General information about the APIC Audit Program
  • 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:

  • Atropine
  • Butylscopolaminiumbromide
  • Digoxin
  • Dihydroergotamine
  • Epinastine
  • Epinephrine
  • Etilefrine
  • Homatropine
  • Hyoscine-n-butylbromide
  • Metildigoxin
  • Phenylephrine
  • Scopolamine
  • ... and the respective salts of the above compounds

The dates for the next Re-Audit have not been determined yet.

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

becker@api-compliance.org