Central to our quality ethos is a focus on simplifying systems to ensure our standards and controls are tailored to each phase of a project, enhancing flexibility, readiness and efficiency to meet client needs and regulatory requirements throughout the product lifecycle.
Our quality management system is largely digital which facilitates tracking and improves accuracy. The metrics are used as the basis for a data-driven approach to quality and compliance, with benchmarking against world-class standards further underlining our quality commitment.
This year our facilities underwent 87 client and regulatory audits. A notable achievement was securing the US FDA approval for our API facility in Mangalore.
GCP
GLP
Certification surveillance audit/renewals
We continued to implement digital and automation tools to complement our quality system, especially in the quality control laboratories where we have transitioned to majority paperless operations. This shift not only reduces the potential for human error and data integrity issues but also enhances traceability and compliance. Moreover, reducing our paper usage supports our environmental sustainability efforts while lowering operational costs.
Our move towards paperless systems for all qualifications and validations represents a major leap towards digital efficiency which is expected to reduce the review and approval cycle significantly. This transformation not only saves time but also eliminates the need for physical archives, further enhancing our eco-friendly practices.
During the year, we embarked on a pilot project using artificial intelligence and machine learning to expedite the review of investigation reports through natural language processing (NLP). This pilot, conducted with the Biologics team has been designed to reduce the investigation report review cycles, thereby enhancing efficiency and responsiveness.
We commissioned a new state-of-the-art Biologics Quality Control and Microbiology Laboratory, meeting world-class quality standards and equipped with an interconnected digital infrastructure and the latest augmented reality technology. The existing biologics quality control laboratory expanded its capabilities with the addition of sterility testing.
The Small Molecule QC laboratory enhanced its capabilities by digitizing forms, checklists, instrument usage logbooks, and integrating them into the Electronic Lab Notebook/LIMS
Syngene secured the first runner-up position in the ‘Large-scale Model TQM company category’ at the Confederation of Indian Industries (CII) Total Quality Management Awards (TQM) 2023-24.
