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.
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