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The Thousand Oaks, Calif., cell therapy manufacturing facility now houses new production suites, updated development labs, and more after expansion.
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Contract service providers must step up their game to stay competitive in increasingly complex bio/pharma market.
SOCMA and EFCG Urge for Reform in FDA Inspections of Foreign Drug-Manufacturing Facilities
March 17th 2011The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.