A Call for FDA Inspections - Pharmaceutical Technology

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A Call for FDA Inspections
FDA must increase inspections of foreign API manufacturing facilities as more production moves offshore.

Pharmaceutical Technology

In their joint position paper, SOCMA and EFCG called for increased foreign inspections based on the changing pattern of API supply into the US and EU. The joint statement specified that the level of foreign inspections has not kept pace with changing supply patterns. "In 2005, FDA conducted 163 inspections of foreign API manufacturers, of which 14 (9%) of the API inspections were in China, 23 (14%) were in India, which is not proportional to the quantity of API being imported," said the SOCMA-EFCG statement. The position paper estimates that around 80% of the volume of APIs that are used to make the drugs in the EU and US come from abroad (1).

—Patricia Van Arnum, senior editor, Pharmaceutical Technology


1. "Uneven Enforcement Leads to Sub-par Drugs and National Security Risk," European Fine Chemicals Group (EFCG, Brussels, Belgium) and the Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC), http://www.socma.org/PDFfiles/bptf/EFCG-SOCMA_common_position_paper.pdf accessed Aug. 1, 2007.

2. G. Villax and C.Oldenhof, "Global API Sourcing: What is Next for Suppliers to the European Union," Pharmaceutical Technology Sourcing and Management 2 (7), e10–e19 (2006), http://www.nxtbook.com/nxtbooks/advanstar/ptsm0706/

3. P. Van Arnum, "The EFCG Looks to Add Muscle to New European Legislation," Pharmaceutical Technology Sourcing and Management 2 (3), e4–e20 (2006), http:// http://www.nxtbook.com/nxtbooks/advanstar/ptsm0306/


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