Q U A L I T Y M A N A G E M E N T
Advancing Innovation
with Quality Discipline
Regulatory compliance continues to be reinforced through paperless, digitally-enabled Quality Control (QC), strong inspection outcomes and a prevention-led shift that embeds quality into daily operations, with the line taking primary ownership.
Digitization and automation continued to scale across QC, with paperless execution now established across GMP QC and digitization completed for commercial products in Biologics QC and Microbiology. Building on this, teams focused on improving productivity, consistency and robustness. In parallel, the operating philosophy further evolved, with sharper emphasis on leading indicators such as right-first-time analysis and right-first-time documentation.
Delivery capability strengthened across the network. In Small Molecule QC, analytical turnaround efficiency improved materially through tighter execution discipline and continuous improvement programs. A structured Phase Gate process for analytical method development and transfer strengthened risk identification, mitigation planning and learning loops, reducing incidents during method transfer and early-stage GMP QC execution.
Capability and capacity investments supported growth and complexity. A new bioassay lab was commissioned in Unit 3 to expand Biologics QC capacity and capability. Renovation of the Small Molecule QC Lab progressed with two phases completed to support incremental capacity addition. Ongoing Bayview integration remained an important workstream, with leadership in place and quality system alignment progressing between India and the USA.
Regulatory inspections, accreditations and certifications
| Area | Agency/Standard | Site/Scope | FY26 Outcome |
|---|---|---|---|
| GMP | U.S. FDA | Large Molecule, Small Molecule Drug Substance, Small Molecule Drug Product and Stability facilities. | Responses to Form 483 observations were accepted, and the inspection was closed. |
| GLP | National GLP Compliance Monitoring Authority (NGCMA), Government of India | GLP facility | GLP compliance successfully recertified |
| GCP | U.S. FDA | BA/BE study audit | Inspection completed and classified as NAI (No Action Indicated); study data accepted for market authorization |
| Bioequivalence / Phase 1 |
CDSCO | BE / Phase 1 facilities, procedures and practices | Facility inspection completed |
| Central Lab | CAP | Central lab | Reaccredited |
| Central Lab | NABL ISO 15189:2022 | Central lab | Reaccredited |
| IMS | ISO 9001:2015, ISO 14001:2015, ISO 45001:2018 | Five operational units/facilities (Bengaluru and Mangaluru) | Certification successfully completed |
| Energy | ISO 50001:2018 | Mangaluru unit; Bengaluru units audit completed | Mangaluru recertified; Bengaluru certification awaited |
| Biologics facility | U.S. FDA Establishment Inspection Report (EIR) | Biocon Park | EIR issued with favorable Voluntary Action Indicated (VAI) outcome |