Muenster (Germany), 22. April 2009. On April 14th, 2009 the European Directorate for the Quality of Medicines & HealthCare (EDQM) has suspended the Certificates of Suitability of four active pharmaceutical ingredients (APIs) manufactured in China. Two Benzylpenicillin products (R0-CEP 2004-001-Rev 00, R0-CEP 2004-017-Rev 00) of the company Hebei Huari Pharmaceuticals Ltd. as well as Dihydrostreptomycin sulphate (R1-CEP 2000-069-Rev 00) and Neomycin sulphate (R0-CEP 2001-317-Rev 02) of Sichuan Long March Pharmaceutical Co. Ltd are affected. “The EDQM auditors have obviously detected that these APIs are not manufactured according to the submitted documentation or in line with the requirements of ICH Q7”, explained Dr. Wolfgang Heisig from the blue inspection body GmbH (www.blue-inspection.com) the proceedings of the EDQM. “Since the associated risk has changed, European pharmaceutical manufacturers should now also assess those APIs manufactured in the same premises, which have not been objected”.

Already in mid of March the “Certificate of Suitabilty” for Clindamycin phosphate (R0-CEP 2003-060-Rev 00) of Zhejiang Pharmaceutical Co. Ltd. had been suspended by the EDQM. The Spanish Ministry of Health had thereupon demanded to recall 14 batches of medicinal products which contained the objected Clindamycin phosphate. In addition, GMP audit reports of Chinese suppliers were asked for from the pharmaceutical manufacturers.

“We currently do not know whether other health authorities will follow in that direction”, comments Dr. Wolfgang Heisig. However, pharmaceutical companies using APIs from the affected companies should act now. He illustrated: “A change of the supplier is not always mandatory. Additional measures such as GMP audits and more detailed quality analyses may also be appropriate actions which should in advance be confirmed with the relevant authority.”

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