“Embedded in Lupin is a formula for growth which fuels creativity, performance and innovation”
It was Dr. Desh Bandhu Gupta’s vision and passion which helped him grow a small dream into a large company with a global footprint.
The most advanced pharmaceutical product development
Progressing towards the development of
Producing quality medicines in areas of
Producing high quality affordable
and accessible biologics
The importance of quality cannot be undermined in any organization. The customers both in India and overseas are becoming increasingly demanding with respect to cost, quality and delivery performance. Achieving these three require imbibing the philosophy of 'Total Quality Management' into the organization's culture. At Lupin, it is the very essence of our operations.
At Lupin, we take pride in maintaining superior quality at every stage of our processes. That we ensure and assure. Our operations are guided by our Quality Policy. We believe that quality is the backbone of competitiveness. Thus, we constantly create an environment of Quality and Compliance in line with the global best practices.
Quality Assurance is defined as the process of 'providing confidence that requirements will be met through highest quality' and thereafter systematic activities are put in place to ensure quality requirements for a product or service are fulfilled.
The Corporate Quality Assurance (CQA) cell at Lupin works as a link between research & manufacturing for quality products for customers. It targets at ensuring that the Lupin Group follows a standardized common quality system ensuring consistency, effectiveness and efficiency while manufacturing APIs and formulations at all sites. The Company now has a host of drug delivery platforms that have already been developed.
- Establishing Quality Standards
- Developing processes to achieve those standards
- Monitoring to ensure Compliance
- Upgrading technology standards
- Training personnel on quality aspects
Lupin global quality team is engaged in driving the quality philosophy of the organization and assuring that the global standards of good manufacturing are implemented in the best form and spirit at every location during each process.
CQA monitors the effectiveness of Site Quality organization and Contract Manufacturing Quality organization through periodic quality reviews, periodic audits, budgetary reviews and review of compliance to regulatory inspections and customer audits. Quality reviews focus on review of failures, rejections, market complaints, deviations, non-compliances, product stability, various Corrective and Preventive actions planned, productivity, cost of quality etc. CQA also supports the site Quality organization by providing necessary resources, technical guidance and training. CQA endeavors to upgrade skills and competence levels in QC / QA function by introducing advanced technologies. Enterprises that exemplify leadership in quality not only deliver quality products and services, but also effectively set industry benchmarks and redefine standards for those who share their mission.
- The Company shall establish and maintain high standards of quality for its products manufactured at various sites, including those at contract manufacturing sites, meeting cGMP and cGLP norms.
- Products shall be manufactured and marketed meeting all quality parameters related to identity, purity, safety and efficacy through well-defined quality assurance and validated systems.
- The Company shall comply with current national and international regulations as applicable and continuously strive for achieving stringent global standards. Major thrust shall be given on quality upgrade and product integrity on a continuous basis to achieve a higher level of customer satisfaction.
- Continuous training shall be given to the employees in the organization to enhance their skills in performing their assigned tasks.
We believe Quality and Regulatory Compliance not only have to be embedded into the product but must be built into people, systems, and processes through a systematic process of continuous training and knowledge sharing.
The Company today has over 700 Global Corporate Quality Assurance professionals spread across all manufacturing locations engaged in developing and implementing policies that ensure quality and compliance with global regulatory standards. Consistency in meeting customer expectations and meeting regulatory quality and compliance norms are the true enablers and the critical differentiator that has made Lupin the global generic powerhouse it is today.
As Lupin aspires to accelerate and scale higher orbits of growth, we are conscious of the fact that product and market complexity will increase exponentially. We are aware that the Company needs to stay ahead of the curve by continuously investing in new technology, automation and systems to create better efficiencies that enhance profitability. We are also investing prudently in expanding our manufacturing operations by setting up new facilities and plants to meet future demand. We actively engage with leading consulting organizations to build a manufacturing operation second to none and continuously sharpen our compliance ethic.