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

Following an inspection of Saga Lifesciences Limited, an Indian pharmaceutical manufacturer, the Maltese authority issued a non-compliance report. This inspection served as a follow-up to a previous one conducted in 2022, aiming to monitor the implementation of measures. However, the authority found persistent deficiencies and cross-contamination risks.

In 2022, inspectors identified three serious and seventeen other GMP deficiencies. During the follow-up, they found three critical, two serious, and six other deficiencies, some previously noted in 2022 and not fully resolved.

Critical deviations included HVAC system maintenance inadequacies leading to cross-contamination risks, visibly dirty production equipment labelled as clean, and data integrity violations in the QC laboratory. Serious deficiencies involved the self-inspection program and documentation practices.