Investing In Quality

It is our firm conviction that quality is non-negotiable and must be manifested across every process, input, output and endeavour of our organisation. This unflinching focus and continual investment in quality has made it one of our key differentiators.

Drug discovery, development and manufacturing is a serious responsibility. Meticulous care must be taken to ensure adherence to the highest standards of quality and safety across every phase of the discovery and development process. Spread over 1.4 Mn sq. ft., our research and manufacturing facilities in Bengaluru are accredited by major global regulatory authorities. Our quality management systems are continuall monitored, evaluated, and upgraded to meet evolving industry regulations and industry best practices.

During the year, we strengthened the overall quality function by appointing a Chief Quality Officer. We also enhanced the quality governance structure, bringing in greater accountability and ownership across all levels.

We continue to strengthen the quality process with the implementation of digitisation and electronic Quality Management System (e-QMS) tools. The use of these tools enable us to keep pace with the evergrowing number of processes and documentation in R&D and manage compliance and risk efficiently.

INVESTING.SUCCEEDING.
Over the past four years, we have successfully cleared seven USFDA audits of our facilities
QUALITY ASSURANCE CERTIFICATIONS AT SYNGENE
  • USFDA approval for Formulations Centre
  • Certification as per ISO 13485:2016 requirements
  • Certification as per ISO 9001:2015 requirements
  • G MP certification from Karnataka Drugs Control Department, Government of Karnataka, for Formulation Centre
  • G LP certification from National GLP Compliance Monitoring Authority (NGCMA), Department of Science and Technology, Government of India, for Large Molecule Bioanalytical laboratory
  • Renewal of College of American Pathologists (CAP) certification for Syngene Central Laboratory