Choosing the Right Dimension of Purity
Croda
Last week the EDQM suspended the certificates of suitability of four APIs manufactured in China, adding to the one in March that sparked the recall of 14 products in Spain.
The move by the European Directorate for the Quality of Medicines & HealthCare (EQDM) affects: two benzylpenicillin products manufactured by Hebei Huari Pharmaceuticals; and dihydrostreptomycin sulphate and neomycin sulphate produced by Sichuan Long March Pharmaceutical.
Other active pharmaceutical ingredients (API) made at the facilities are unaffected but the blue inspection body GmbH has advised companies to reassess products they receive from the plants.
Wolfgang Heisig from the blue inspection body GmbH added: “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.”
