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


Synthetic Organic Chemical Manufacturers Association and European Fine Chemicals Group Unite on Foreign Inspections

The Synthetic Organic Chemical Manufacturers Association ( http://www.socma.org/) (SOCMA, Washington, DC) and the European Fine Chemicals Group ( http://www.efcg.cefic.org/) (EFCG, Brussels) are two organizations that have taken an active role in calling for an increase in inspections of foreign manufacturing facilities of active pharmaceutical ingredients (APIs).

SOCMA is the US-based trade association representing chemical batch and custom manufacturers, which includes contract manufacturing organizations producing APIs and intermediates to the pharmaceutical industry.

EFCG, which was formed in 2004 to address the issue of growth and competitiveness among European fine chemical companies, is part of the European Chemical Industry Council (Brussels http://www.cefic.org/ the European trade association representing chemical manufacturers. EFCG consists of 200 companies and six national trade associations representing European fine chemical companies.

Last fall, SOCMA and EFCG issued a joint position paper on the need for more inspections of foreign API manufacturing facilities (1). The move followed the 2006 submission of a citizen petition to FDA by SOCMA's Bulk Pharmaceuticals Task Force (BPTF), which had asked the agency to increase inspections of drug-manufacturing facilities located outside of the United States. The petition may be found here http://www.socma.org/PDFfiles/NewsReleases/BPTF_Citizens_Petition_Foreign_InspectionFINAL.pdf

In filing the citizen's petition, SOCMA asserted that nearly half of all drugs marketed in the United States are produced or manufactured in foreign facilities, but that the vast majority of FDA inspections occur domestically.

The petition outlined recommendations for improving FDA's ability to reduce the risks from drug products imported into the US. "Currently, the FDA inspects facilities according to a risk-based formula that weighs a variety of factors," said SOCMA in a 2006 release. "Being a foreign facility is not a factor in the formula." Based on that finding, the BPTF made three recommendations in the petition:

  • Ranking foreign and domestic drug manufacturing firms together to allow for better comparisons of the risks from foreign and domestic manufacturers
  • Listing "foreign facility" as a significant risk factor for determining facility inspections
  • Creating a program to monitor the impurity profiles of imported over-the-counter drugs for patterns creating the appearance of underlying problems in complying with current good manufacturing practices to allow FDA to refuse entry to products appearing adulterated.

The EFCG also has taken an active role in is raising concerns over the preparedness of the European Union and European national regulatory authorities in implementing recent EU legislation, EU Directives 2004/27 and 2004/28, which became effective October 2005. The laws require that all medicines marketed in the EU be made with APIs that comply with the harmonized GMP standard ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. ( http://www.ich.org/cache/compo/276-254-1.html. EFCG) EFCG has drawn attention to the need for increasing foreign-inspection resources and improving enforcement measures by EU and national regulatory authorities in the EU (2, 3).

These measures come as the supply patterns of APIs into the EU have shifted from domestic sources to offshore sources. European producers supplied more than 80% of APIs into Europe in the 1980s, but now supply less than 30% of APIs coming into Europe (3). In the 1980s, India and China accounted for less than 10% of API supply into Europe, but now supply more than 70% of APIs into Europe (3)


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