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At Lupin, Quality is a way of life that is driven by rigorous discipline, unfailing checks, and unwavering commitment. Our operations are guided by our Quality Policy and we take pride in maintaining and monitoring it at every stage of our processes. We have an established Corporate Quality Assurance (CQA) function, which links our research and manufacturing verticals, ensuring a standardized common quality system and guarantees consistency, effectiveness and efficiency while manufacturing APIs and formulations at all our sites.

Our ‘Quality First’ mandate is a critical regulatory compliance check, which considers every strategic imperative for re-examination and re-evaluation, thereby improving our core manufacturing operations and aligning them with our aspirations. The ‘Quality First’ program constitutes a set of values that act as guidelines to create a culture where we strive to provide the best ‘quality’ output. The purpose of this program is to make an orbital change in our procedures, investigation methods, corrective action plans, training effectiveness, and product robustness.

As a part of the ‘Quality First’ program, the Process Development Lab (PDL) along with the Operational Excellence (OPEX) team has initiated the development of a framework that can evaluate the robustness of our products and provide insights on areas of improvement. This is primarily done to enhance the quality of our products, using the ‘Six Sigma’ methodology. Under this process, we have taken up more than 50 molecules for improvement. The ‘Six Sigma’ process provides Lupin with the tools to improve the capability of our production processes by increasing performance, improving profits, and eventually, boosting the quality of our products. We have successfully completed 28 projects by achieving the desired ‘Six Sigma’ level of quality, and work is in progress to achieve the same level of quality in the other identified projects.

We have also initiated the World Class Labs program, which targets to bring Quality Control in our laboratories to a high Sigma level of quality in invalid Out-of-Specification results as well as laboratory incidents. After a pilot, these solutions are now being cross deployed in all our other labs.

Under this program, A number of process innovations have been identified and implemented, including regrouping of various subsections of our Quality Control laboratories, column performance improvement, communication error reduction by implementing the learnings from OEMs and software upgradation, reduction in inadvertent errors by lab analysts. The program also encompasses reducing movement in the lab through appropriate division of labor and efficient systems which aid in allocating glassware and chemicals, thus allowing analysts to focus on their critical tasks.

We also have a 5S program underway. In the upcoming fiscal, all labs are targeted to be brought to 3S level and upon achievement of this, Lupin will focus on getting them to 5S.

We are aware that our analysts are the key for success of our World Class Labs program. A detailed plan has been developed in partnership with HR focused on fostering learning and training, and implementation of a reward and recognition program for high performing individuals who achieve quality improvement.

Strengthening our systems on quality, is a continuous process. To achieve this, we prepared a Global Quality Action Plan, a holistic approach, which takes into consideration the entire cycle of a quality process, right from recruiting to driving global standardization under a single quality system across all our manufacturing entities.

With over 2,600 professionals in Quality alone, we are constantly engaged in developing and implementing policies that ensure compliance with global regulatory standards. At Lupin, we truly believe that upholding regulatory and compliance norms is the true enabler of superior quality, and acts as a critical differentiator.