Non-Compliance Report for Indian API manufacturer

Recommendation

10-12 October 2023
Munich, Germany

Product Transfer
Organisation of a GMP-compliant Site Change

During an inspection in March 2018, the French competent authority discovered various GMP violations at the site of an Indian manufacturer. The manufactured product was a beta-lactam antibiotic. The manufacturing steps drying, milling and blending had been inspected as well as the primary and secondary packaging. The quality control for physical/chemical and microbiological testing had also been part of the inspection.

Overall, 24 deficiencies were found, one of which had been classified as critical and eight as major. The critical deficiency observed concerned multiple cross contamination risks. The deficiencies listed in the category "major" were about:

• Insufficient CAPA management
• Insufficient maintenance of facilities
• Lacking control of water quality
• Various deficits in the area of equipment and its maintenance
• Insufficient storage management
• Various validation deficits
• Failing change control management system

As a consequence, the risk-based recall of all batch produced at the facility should be considered. Furthermore, the EDQM should consider withdrawing the CEP.

Source: EMA EudraGMDP database