Non-compliance Report (EudraGMDP): Cross-Contamination Risk at Indian pharmaceutical Company

A non-compliance report was issued by the inspecting Maltese authority following an inspection of an Indian pharmaceutical manufacturer. The inspection was the follow-up inspection to an inspection already carried out in 2022, which was intended to monitor the implementation of the measures. In the opinion of the authority, the still existing deficiencies and risks of cross-contamination were problematic.

Three serious and seventeen other GMP deficiencies were identified during the inspection in 2022. During the follow-up inspection, the inspectors found three critical, two serious and six other deficiencies, some of which had already been identified during the previous inspection in 2022 and had not yet been fully remedied.

The critical deviations related to the HVAC system. According to the authorities, the maintenance of the pressure cascades to prevent cross-contamination was not ensured. This deficiency had already been identified in 2022 and has therefore now been upgraded from serious to critical. The inspectors also found the inadequate cleaning of production equipment to be critical. Equipment was labelled as clean, but was in fact visibly dirty. The inspectors from the Maltese authority also disagreed with the cleaning validation and also saw a risk of cross-contamination as a result. The third critical point concerns the QC laboratory and the data integrity violations found there.

Other deficiencies classified as serious relate to the self-inspection programme and the company's documentation practices.

Based on this inspection result, the Maltese Medicines Authority has issued a non-compliance report in accordance with Directive 2003/94/EC for the Indian manufacturer's site.

Source: EudraGMDP Database (Inspection Date: 29 November 2023; Referece Number: 166971; Report Number: 015/2023/MC/ya). *

* To find the respective report, please click on "Non-Compliance Reports" in the menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.