The certificate on non-compliance with Good Manufacturing Practice (GMP) was issued following a visit to the firm’s facility in Hohhot, Inner Mongolia by Belgium’s Federal Agency for Medicines and Health Products in October 2017.
According to the report filed on the European Medicines Agency’s (EMA) EudraGMP database today, the Agency found one critical and eight major deficiencies in the firm’s production of the drug substance for antibiotic Amoxicillin trihydrate, a semisynthetic derivatives of 6-aminopenicillanic acid (6-APA).
“The critical deficiency is related to the QA system implemented on site which was found to be weak and not capable of putting in place proper design, planning, implementation, maintenance and continuous improvement of a system that allows the consistent delivery of products with appropriate quality attributes,” the report states.
“Therefore a risk to the safety of patients could not be excluded. This was evidenced by the high number of major deficiencies observed in the following areas: Deviation, Management, Storage, Materials Management, Quality Control, Validation, Qualification, Complaint Management, and Documentation.”
The visit – the first carried out by an EU regulator at the facility – led to the inspection team recommending the suspension of the firm’s Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs), something endorsed by the European Directorate for the Quality of Medicines & HealthCare's (EDQM) Ad Hoc Committee on November 13.