EDQM suspends cert for Chinese APIs

The European Directorate for the Quality of Medicines & HealthCare has suspended the Certificates of Suitability of four active pharmaceutical  ingredients manufactured in China. Two benzylpenicillin products  (R0-CEP 2004-001-Rev 00, R0-CEP 2004-017-Rev 00) from Hebei Huari  Pharmaceuticals, 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 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 Wolfgang Heisig from the blue  inspection body GmbH. "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," he  added.

In mid-March, the Certificate of Suitabilty for clindamycin phosphate  from Zhejiang Pharmaceutical was suspended by the EDQM. In that  instance, the Spanish Ministry of Health had demanded the recall of 14  batches of medicinal products which contained the offending  clindamycin phosphate.