Shanghai, Beijing (China), Muenster (Germany), 15 July 2013 – More than 100 participants from industry, authorities and inspection bodies discussed suitable measures to adequately control impurity levels in APIs during the “EU CEP Symposium 2013” in Shanghai. The seminar, which was held directly after the CPhI China in Shanghai, was organized by the Chinese Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) and the European Directorate for the Quality of Medicines and HealthCare (EDQM). Main priorities of the seminar were the European procedure of the so called „Certificates of Suitability” (CEP) for APIs and the inspections of API manufacturers by the EDQM and the World Health Organization.
Dr. Stefan Kettelhoit, Lead-Auditor of blue inspection body GmbH (www.blue-inspection.com) summarizes: “Besides the traditional impurities, such as residual solvents, complex impurities like by-products from fermentation processes or heavy metals from catalysts are more and more targeted for review during audits and health authority inspections.” This is applicable, for instance, for antibiotic APIs. These products are in many cases manufactured in China, exported to the EU where they are processed into finished drug products. During the seminar in Shanghai Dr. Andrew McMath, EDQM, highlighted the „Guideline on setting specifications for related impurities in antibiotics“. The guideline came into force on 30 June 2013 and provides guidance for European manufacturers on the quality assurance of APIs from fermentative processes. Due to the global supply chain this new EMA-Guideline is also immediately applicable for Chinese manufacturers.
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