Case studies
Financial statements
At Syngene, quality goes beyond procedures and is a company-wide commitment to best practices and regulatory compliance. Our Right First Time philosophy minimizes errors, ensuring product safety and efficacy. We invest in continuous skill development and training to keep our workforce aligned with global standards and emerging industry trends.
Syngene’s digital transformation in Quality includes key initiatives such as LIMS upgrades for paperless operations, and RealWear devices for remote audits in Small molecule QC laboratory. The Scientific Data Management System (SDMS) integrates laboratory instruments for seamless data analysis, while predictive analytics optimize GMP QC scheduling in Biologics QC laboratory.
Electronic logbooks and TrackWise improve traceability, and digitalization at Syngene Unit-III (SU3) enhances quality management with systems like SAP, LIMS, and eLN.
We expanded our infrastructure to meet growing operational needs, commissioning new In-process quality control (IPQC) and microbiology labs at SU3 and starting environmental monitoring. The SU3 drug substance facility was repurposed and requalified. At our Mangaluru facility, the OEB IV-compliant equipment was installed for potent product handling.
In Biologics QC laboratory, we also integrated advanced analytical technologies like SEC-MALS, Spectramax i3x, iCE, and CE systems.
Through continuous improvement, we implemented two Green Belt projects, achieving improved audit scores, and Right First Time.
Quality training hours in FY25
In FY25, Syngene underwent an unprecedented 111 audits, including client and regulatory inspections.
| Category | Regulatory Authority | Outcome | Scope |
|---|---|---|---|
| GLP Audits | National GLP Monitoring Authority (NGCMA) | Positive | GLP certification surveillance audit (Safety Assessment, VTF & LM Bioanalytical) |
| National Accreditation Board for Testing and Calibration Laboratories (NABL) | Positive | ISO/IEC 17025:2017 certification (Safety Assessment) | |
| GCP Audits | ANVISA (Brazilian Health Regulatory Agency) | Positive | Surveillance inspection of four studies (Bioequivalence / Phase 1 facilities of Clinical Development) |
| Small Molecule & Biologics Audits | USFDA | Positive | Pre‑authorization inspection for biologic drug substance; GMP inspection for commercialized small molecule drug substance, drug product, and stability studies |
| European Medicines Agency (EMA) (Federal Agency for Medicines and Health Products (FAMHP) & VMD) | Positive | Pre‑authorization inspection for biologic drug substance | |
| Health Canada | Positive | GMP inspection for biologic drug substance, small molecule drug substance, small molecule drug product, and stability studies | |
| Other Regulatory Milestones | The Central Drugs Standard Control Organization (CDSCO) (India) | Approved | Approval of Biologics Laboratory and Raw Material laboratory for in‑house testing |
