37 Quality management is a complementary force in co-creating value with our customers. Sai’s Quality Systems meets the requirements of Indian Regulatory- Schedule M, ICH Guidelines, ISO 9001:2015, EMA Guidelines and PMDA Guidelines, 21 CFR part 210, 820 etc. During the reporting period multiple customer audits and regulatory audits of DCA were successfully completed. The Unit IV Bidar Facility has received approval pursuant to audits conducted by the USFDA, the PMDA, COFEPRIS Mexico, and it has undergone more than 250 audits by our customers until FY 24. We offer our customers state of the art facility and electronic systems which support transparency and an open environment that foster product responsibility and regulatory compliance. In the reporting year we underwent 33 successful audits across our R&D and manufacturing sites. The key feedback points from our customers indicate their satisfaction with our Quality management system: • Robust Quality system and is set a benchmark standard • Implementation of the electronic system shows transparency, commitment, and reliability of data • Procedures are elaborate • GMP Pro is user friendly and provides easy traceability of documents • Work ethic and Quality culture is impressive The key initiatives that are making R&D and process development quality centric are Quality by design, comprehensive and data centric approach to quality with Biovia and Electronic notebook implemented at R&D provides the transparent, accurate, legible, traceable and contemporaneous data related to Design of experiments (DoE). The design of technology transfer in a structured way ensures knowledge transfer and shop floor gemba walk, monitoring of the activities at the shopfloor by CFT and handholding of CFT during process transfer ensure safe and reliable execution to obtain a quality product output. Unit Total no. of Audits Critical Observation Unit II 4 None Unit III 2 None Unit IV 27 None Quality Management We remain committed to the journey of innovation, collaboration, and scientific excellence in co-creating value. We see sustainable science, and efficient commercialisation approaches as critical enablers to developing manufacturing processes that provide environmental and economic benefits. Three of the 32 small molecules that secured FDA Novel Drug Approvals in 2023 traversed Sai’s laboratories during their discovery, development and manufacturing stages. We have been part of the journey of over 10% of all small molecule approvals in each of the last four years, demonstrating a consistency in the quality of science we do, and our resolve to support innovators bring new medicines to life. Our capabilities in complex chemistry, advanced chemical synthetic approaches (such as chiral chemistry, biology and chemistry catalysis), advanced production technologies (such as flow chemistry, column chromatography, lyophilization, cryogenics and high pressure reactions) and comprehensive analytical testing methods (such as solid state characterization and structure elucidation) allow us to service a wide range of customers’ specific needs ranging from conventional small molecules to highly potent oncology APIs (HPAPIs), peptide APIs, contrast agents to building blocks of oligonucleotide and other RNA based therapeutics. We also continue to implement robotic automation, automated liquid handling, real-time data acquisition and parallel experimentation in both our Discovery and CMC R&D laboratories. Our manufacturing infrastructure and equipment are built with a high degree of containment, automation and connectivity to increase safety, precision of data collection and ensure that the final products manufactured consistently meet the required quality standards. Additionally, we have been running a comprehensive operations excellence program “SaiGo” since 2019. Under this program, we have implemented a “Shopfloor Transformation Initiative” across our R&D and manufacturing platforms to improve the rigor of daily operations management. We also regularly conduct “Kaizen Blitz” drives for employees to proactively identify process improvement and cost saving opportunities. Each year, we also design and implement operations transformation initiatives to drive improvements in raw material usage, energy efficiency, water conservation, reduction in hazardous waste generation and green chemistry. Accelerating science and technology
RkJQdWJsaXNoZXIy MTIwMDc4NQ==