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

 

On 27 - 28 March 2017 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 6 customers of Pfizer.

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:

Primary Products:

  • 16-alpha-Hydroxyprednisolone
  • Lincomycin
  • Neomycine sulphate
  • Dexamethasone micronized

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

  • Hydrocortison
  • Hydrocortison Acetate
  • Dexamethasone 8DM
  • Prednisone anhydrous
  • Progesterone
  • Testosterone
  • Testosterone Cypionate
  • Testosterone Propionate
  • Testosterone Undecanoate
  • Triamcinalone 3

Due to the structure of the APIC Audit Program, 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.

The dates for the next Re-Audit have not been determined yet.  Please contact us if you are interested in the report from the Re-Audit in 2017 or if you want to initiate the next Re-Audit.