APIC Audit at Pfizer's manufacturing site

On 15 - 16 March 2010 a regular Re-Audit at Pfizer Global Manufacturing in Kalamazoo was performed. A re-Audit is recommended every 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 19 and 20 November 2007, a first APIC Audit was performed at Pfizer Global Manufacturing in Kalamazoo in the US on behalf of 9 customers (Qualified Person). More than 20 companies have since purchased the audit report. The Audit Report for the 2010 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 auditee
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:

Betamethyl Epoxide
Dexamethasone
Flumethasone
Hydrocortisone
Hydrocortisone acetate
Lincomycin
Neomycine
Neomycine sulphate

Also covered by quality system analogy:

Dexamethasone Sodium Phosphate
16-alphahydroxyprednisolone
Hydrocortisone hemisuccinate
Megestrol acetate
Methylprednisolone
Prednisone
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.