APIC Third Party Audit at Pfizer Global Manufacturing, Kalamazoo, USA


On 24 and 25 July 2019 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.

This Re-Audit was initiated by customers of Pfizer.

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:

Primary Products covered:

  • Dexamethasone,
  • Hydrocortisone Acetate,
  • Megestrol Acetate,
  • Neomycin Sulfate,
  • Progesterone,
  • Testosterone

Secondary Products covered (by Periodic Quality Review evaluation and quality system analogy):

  • Dexamethasone Acetate,
  • Dexamethasone Sodium Phosphate,
  • HDF,
  • Hydrocortisone Hemisuccinate monohydrate,
  • Lincomycine HCL,
  • Testosterone Cypionate,
  • Testosterone Propionate,
  • Testosterone Undecanoate,
  • Triamcinalone 3

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.

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