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. It has to become the very essence of the organization. More so in the case of the pharmaceutical industry.
The pharma industry is subject to strict quality control and scrutiny. India by far has the largest number of USFDA approved plants, outside of US which exemplifies the increasing focus on quality assurance of the industry.
At Lupin, we take considerable pride in the quality that we ensure and assure. Our operations are guided by our Quality Policy. We believe that quality is the mainstay of competitiveness. We thus 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 there after 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 during the manufacture of APIs and formulations at all sites.
The CQA focuses on:
- Establishing Quality Standards
- Developing processes to achieve those standards
- Monitoring to ensure Compliance
- Upgrading technology standards
- Training personnel on quality aspects
The 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 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 also continuously 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. At Lupin we are constantly endeavouring to achieve excellence.