Shared Audit at Pfizer's Manufacturing Site in the US

The "APIC Audit Programme" is a third-party audit programme for auditing API manufacturers, distributors and API contract manufacturers and/or contract laboratories. It is the aim of the APIC Audit Programme to offer an independent GMP compliance audit of API manufacturers and/or distributors, including organisation, conduct and evaluation of the audit.

On 15-16 March 2010, a regular re-audit was performed at Pfizer Global Manufacturing in Kalamazoo, USA. 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.

An 'APIC Audit' within the framework of the APIC Audit Programme can be initiated by one or more QPs of one or various manufacturing authorisation holders in order to get independent information about the GMP compliance status of the API supplier. On 19 and 20 November 2007, a first APIC Audit was performed at Pfizer Global Manufacturing in Kalamazoo on behalf of 9 customers (Qualified Persons). More than 20 companies have purchased the audit report since. The audit report for the 2010 re-audit is now available. More information is available here.

Source: API Compliance Institute press release:

The latest update on the APIC Audit Programme will be presented at two forthcoming major events: the European API Conference in Barcelona and the QP Forum Auditing Conference in London.

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