Numerous GMP deviations identified at Hebei Dongfeng Pharmaceuticals

EU GMP inspectors found 26 GMP deficiencies at Chinese API Manufacturer Hebei Dongfeng Pharmaceuticals. As a result, a GMP Non-Compliance Report was issued and entered into the European database EudraGMDP.

The products affected were doxycycline hyclate and doxycycline monohydrate. According to EudraGMDP, a total of 26 deficiencies were found during the inspection. Out of them, the major ones were: not fully implemented Quality Assurance system, problems related to the documentation management, deviation related to material management and qualification of the approved supplier, risk of contamination in the production area & of testing samples and data recording and integrity in the QC laboratory were not in compliance.