Italy bans antibiotic APIs made by Antibioticos do Brasil
According to a post on EudraGDMP, the AIFA team who visited the site last month found problems with maintenance, environmental monitoring and cleaning procedures used in areas where antibiotics like cephalexin sodium are made.
The regulator also said staff demonstrated little awareness of European good manufacturing practice (GMP) standards and raised concerns about the lack of coverage of the topic in training programmes.
“It was noted that a specific training on European GMP (Eudralex vol. 4) was not scheduled; neither a gap analysis between Brazilian and European GMP was performed in order to verify the overlapping of the two guidelines.”
The quality control laboratory at the site was also the subject of criticism.
AFIA said: “The design of the QC microbiological laboratory failed to maintain a rationale material flow in order to prevent a potential contamination during the testing performance.”
Re-inspection
In addition to prohibiting the supply of drug substances and bulk drug products made at the site, AIFA urged the European Directorate for the Quality of Medicines (EDQM) to suspend ABL’s certificate of suitability (CEP) for Ceftazidime pentahydrate with sodium carbonate.
The Rome-based regulator also said that: “Due to the number and nature of raised deficiencies, a new GMP inspection is needed, even if a CAPA plan is submitted, in order to assess effective removal of deficiencies.”
ABL did not respond to a request for comment.
The AFIA comments come just a month after the US Food and Drug Administration (FDA) published a warning letter it sent to the Brazilian firm.
The document details a number of quality problems identified by the US regulator during a visit to the firm's facility last April.
