EU GMP Inspectors from the competent authority in Romania identified several GMP deviations during a GMP inspection at HEBEI DONGFENG PHARMACEUTICAL Co., Ltd, Mingjiao Road Western Yongnian County, Handan, 057 150, China. As a consequence, a GMP Non-Compliance Report has been issued and entered into the European database EudraGMDP.
The products concerned are doxycycline hyclate and doxycycline monohydrate. According to EudraGMDP, a total of 26 deficiencies were found during the inspection. Six of them were rated as major:
1) not fully implemented Quality Assurance system
2) problems related to the documentation management
3) deviation related to material management and qualification of the approved supplier
4) risk of contamination in the production area
5) risk of contamination and cross-contamination of testing samples
6) data recording and integrity in the QC laboratory not in compliance
It is very interesting to see that for the first time the GMP Non-compliance Report also lists known customers of the API manufacturer. The report states: "Known customers Doxycycline hyclate: Sintofarm, Industria, P.S.P. ,Chemifarma, Zetercoop Italy; Ofichem, ORFFA, ALC Netherlands; Divasa Spain; Wins Czech Republik, Remedica Cyprus, Farmabase Brasil, many others in rest of the world. Doxycycline monohydrate: only local market. Finished dosage forms: only local market"
European manufacturers of medicinal products are not allowed to use the APIs concerned from Hebei Dongfeng Pharmaceuticals.