According to a post on EudraGMP, inspectors who visited the facility in Gurgaon, India in February observed 32 deficiencies from EU GMP standards, including critical problems with quality assurance protocols, documentation and materials management.
The plant makes antibiotic active pharmaceutical ingredients (APIs), including the cephalosporin cefixime which is on the World Health Organisation’s (WHO) essential medicines list.
The Halmed inspectors said: “The QA system implemented on site, which related to the workshops that were engaged in the manufacture of cefixime, was found to be weak and not capable of proper design, planning, implementation, maintenance and continuous improvement."
Other deficiencies observed by the inspectors included potential contamination risk in chemical intermediates areas, problems with how raw materials are handled and failure to qualify instruments in the site’s analytical laboratory.
GMP withdrawal
The Croatian agency described the violations as "very severe" and said they pose a risk to patient health. It also recommended that the site’s GMP certificate – GIF-IW-N-4022/161/13 which was issued by Polish inspectors in 2013 – be withdrawn immediately.
Halmed also urged the European Directorate for the Quality of Medicines (EDQM) to suspend three certificates of suitability to the European Pharmacopoeia CEPs issued to Dhanuka and said “no further batches to be supplied to the market.”
Dhanuka did not respond to a request for comment ahead of publication.