Group urges international standard for API inspections

The globalization of API manufacturing has driven down prices but also raised serious quality concerns since the bulk of the production has shifted to countries with lax oversight. A program the FDA is pioneering to share inspection responsibilities with regulators in other countries could serve as the blueprint for a uniform international standard, some European experts say.

Speaking at the CPhI show in Madrid this week, Gian Mario Baccalini said the European Fine Chemicals Group (EFCG) believes mutual recognition agreements between Western regulators may be the best way to insure a safe supply of APIs. He urged the European Medicines Agency (EMA) to move in this direction. He said Europe's false medicines directive didn't go far enough because it relies on drugmakers to audit their suppliers and doesn't require inspections of foreign API plants by EU regulators. He is chairman of EFCG's business committee.

Since 2008, the FDA has been working on a program that would allow it to essentially outsource inspections of active pharmaceutical ingredient manufacturing operations in other countries to other regulators and then reciprocate with inspections it conducts. It is already working with the EMA, the European Directorate for the Quality of Medicines & HealthCare (EDQM), and Australia's Therapeutic Goods Administration (TGA). The idea is that one regulatory agency can rely on inspections and documentation provided by another. There are provisions for asking each other to look into specific areas of concern so that members are sure to get what they need out of a visit.

When it comes Chinese and India-made APIs, Western drugmakers are between a rock and a hard place. They know Chinese and Indian oversight of bulk APIs is insufficient to snuff out substandard producers, but since the two countries produce the majority of APIs, Western drugmakers can't live without them.

Baccalini acknowledged that moving to an international standard would add costs to drugmaking but it also would make sure that everyone meets quality standards, improving the market for those that already do.

"It would cost a lot of money, but from a strategic point of view, everyone agrees this is needed," Baccalini told in-PharmaTechnologist during the CPhI event, which drew an estimated 29,000 attendees.

- download Baccalini's EFCG presentation here
- read the in-PharmaTechnologist story

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