APIC Audit at Pfizer's manufacturing site

On 14 - 15 January 2015 a regular Re-Audit at Pfizer Global Manufacturing in Kalamazoo 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.
On 5-6 December 2012, the last Re-Audit was performed at Pfizer Global Manufacturing in Kalamazoo in the US on behalf of 10 customers (Qualified Person). More than 36 companies have since purchased the audit report. The Audit Report for the 2015 Re-Audit is now available.
The findings of the audit at Pfizer Global Manufacturing Kalamazoo have been summarised in an audit report. The audit report 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 following products were covered during the Audit:

  • Betamethasone
  • Dexamethasone
  • Flumethasone
  • Hydrocortisone
  • Hydrocortisone acetate
  • Neomycine
  • Neomycine sulphate
  • Progesterone
  • Testosterone

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 Pfizer Global Manufacturing will be respected. The report can be purchased from the ACI only with the prior approval of Pfizer Global Manufacturing. Please contact us if you are interested in the report.