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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:
