International Joint API Inspection Pilot Program Sees Positive Results

The international API pilot joint inspection program involving regulatory authorities in the EU, US, and Australia is resulting in rapid sharing of inspection reports for non-compliant sites, follow-up inspections at other facilities owned by the companies found to have non-compliant sites, and prompt notification of regulatory actions taken.

European Medicines Agency (EMA) Scientific Administrator Oliver Gross told the DIA Annual Meeting in June that the pilot program – now extended an additional six months to the end of 2010 – has been successful and has allowed “real collaboration” between the participating agencies.

The EMA official cited a joint inspection of a facility in India conducted by the European Directorate for the Quality of Medicines (EDQM) and Australia’s Therapeutic Goods Administration (TGA) as an example of this collaboration process at work.

The Indian facility was found to be non-compliant.  Because the EDQM is not a national regulatory authority, it could not issue a “non-compliance statement,” so it was issued by TGA, which has a mutual recognition agreement (MRA) with EMA.  TGA then sent a copy of the report to all EU member states.

“Because one site was non-compliant, we had suspicions that another site may be non-compliant also,” Gross commented.  In fact, the other site was inspected and found to be more seriously non-compliant than the first one.  This inspection resulted in product recalls, and the inspection report was shared with all of the pilot participants.

In another case, a Japanese site was inspected by the Italian authority and found to be non-compliant. In addition, TGA found issues with a CAPA the firm had submitted.  The result was a joint inspection by EMA Italian inspectors and TGA in June.

The joint API inspection pilot was initiated in response to several factors:  • increased demand for international collaboration on inspections as part of the Transatlantic Administrative Simplification Action Plan (2006-7) • the heparin contamination situation in 2008 • concerns with globalization of the API supply chain, and the lack of guidance equivalent to Q7 outside the ICH regions (IPQ, Nov./Dec. 2008 Report).

[More on the joint inspection pilot program and results to date is provided for subscribers here.]