Lakshmi Achuta | Assistant General Manager – Quality and Regulatory Compliance
Syngene International Ltd | India

Lakshmi Achuta, Assistant General Manager – Quality and Regulatory Compliance, Syngene International Ltd

Ms. Lakshmi Achuta is a Quality Assurance professional with over two decades of experience in the Biotechnology, Biopharmaceutical, Clinical Research Organization (CRO), Contract Research and Manufacturing Services (CRAMS) industries having initiated her career at Biocon in 1993 and subsequently worked in Clinigene and Syngene. She is experienced in implementing, aligning processes, upgrading Quality Systems and pertinent Management Standards and regulatory requirements (GXP)   (Laboratory Management System, EHS Management System, Information Management System) that enabled personnel to function effectively, improving efficiency across interfacing stakeholders. 

Lakshmi has established the Medical Devices Quality Systems and Development Quality Assurance. She has to her credit establishing the Quality Assurance department, inclusive of Clinical Quality Assurance; and, developed a strategy for harmonizing and centralizing the Quality Systems to align with the Clinical Research industry best practices and relevant regulatory requirements to enhance the CRO’s capability as a full service CRO. She brings with her the experience spanning disparate systems with the proficiency to integrate / align requirements as per Regulatory norms; train and mentor QA and auditors on auditing various systems per regulatory requirements. She has hosted various National and International inspections from Regulators, Certifying Agencies and Accreditation bodies. She is qualified with M.Sc. in Applied Botany (Medicinal and Aromatic Plants) from Bangalore University and M.S. in Quality Management from BITS, Pilani.


Conference Day 2 @ 13:30

Ensuring uniformity of GMP inspections in biologics manufacturing

Countries across the globe are concerned about the safety and efficacy of the drugs supplied. As India expands its biologics supply globally, there is an increased emphasis in ensuring uniformity in inspection requirements for drugs manufactured in India. This panel discusses how global regulators such as US FDA, EMA can work closer together with CDSCO in ensuring uniformity in GMP inspections.
  • Overview of India’s inspection landscape and updates
  • Understanding the differences and overlaps in current standards
  • Exploring ways for various regulators to work closer together, including more combined inspections for newly recruited CDSCO inspectors

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