Quality in Action | Compliance and Safety Standards

Ensuring Quality and Safety in Everything We Do

At Lupin, quality and compliance are cornerstones of our operations and organizational culture, guiding every stage of the product lifecycle, from research and development through manufacturing and distribution. Our steadfast dedication to quality and adherence to regulations guarantees the utmost standards of safety, efficacy, and reliability for patients and healthcare professionals globally. We strive to be best-in-class through continuous collaboration with global regulatory bodies and industry experts. Our goal is to lead with excellence, establishing industry standards through innovation, integrity, and continuous improvement.

Lupin's House of Quality

Lupin’s House of Quality is anchored on the Quality Management Maturity (QMM) model, demonstrating a mature, enterprise-wide approach to quality. It integrates robust systems, digital enablement, and a deeply embedded culture of accountability across the organization.

To strengthen quality execution, Lupin has implemented advanced technologies and automation, that include the following:

Next-Gen Robotics
Electronic Batch Processing Systems
Laboratory Information Management Systems (LIMS)
Electronic Document Management Systems (EDMS)
Quality Assurance Management Systems
Integrated ERP platforms

Our key focus areas

Advanced Pharmaceutical Quality Systems: We employ robust, data-driven systems to ensure consistent product quality.

SMART Quality: We establish an Integrated Smart Quality Control and Digital/AI Infrastructure (such as application of automated PQR, NIR and bar code enabled quality control operations, E-Investigator, continuous regulatory monitor and regulatory intelligence) as the blueprint of Quality Management Maturity (QMM). This is structured around a three-core framework.

Predictive and Proactive Quality Platforms
Transforming the Core Platforms
AI-Based Next-Generation Solutions

Technical Excellence: We continually enhance our team's technical skills via dedicated training and knowledge transfer programs, which include governance through a specialized training academy.

Management Commitment: We foster a culture in which every employee is empowered and committed to quality and patient safety.

Continuous Improvement: We benchmark our processes globally and leverage AI and analytics to reduce errors and enhance efficiency.

Culture of Excellence

Lupin’s quality governance is led by 2,000+ quality professionals and a dedicated Corporate Quality Assurance (CQA) organization. As a team, we ensure:

Robust Regulatory Systems: Our systems are developed based on decades of global expertise and are aligned with international standards including the US FDA, UK MHRA, EU GMP, and others.
Transparent Reporting: We adhere to comprehensive reporting frameworks, including the GRI standards and the IIRC's International Integrated Reporting Framework, demonstrating transparency to all stakeholders.
Cutting-Edge Technology: We integrate advanced technologies and automated operations in our facilities to meet and exceed global standards.
Integrated Assurance and Resilience: We redefine how we safeguard our operations, assets, and reputation through our Integrated Assurance approach.

Regulatory Track Record

Lupin maintains a strong record of successful inspections and approvals from stringent global regulatory authorities. Our sites remain inspection-ready at all times. We are committed to manufacturing and supplying products of the highest quality from all our manufacturing sites, ensuring reliability and trust in the global market.

Community of Practices

Lupin’s Community of Practices (CoP) brings together experts across quality systems, sterile operations, inhalation and combination products, laboratories, and other GMP-critical functions to share knowledge, standardize best practices, and continuously elevate quality standards across all global sites.

Quality and precision in pharmaceutical manufacturing - hand placing vial in controlled facility

Conclusion

At Lupin, quality and trust go hand in hand. Guided by a patient-first philosophy, we embed quality across our operations to deliver safe, effective, and affordable medicines worldwide.

Qualityin Action