A lot has happened over the last six weeks at Biocon Academy. It has been no less than a ’roller-coaster’ ride. The lectures by BITS Pilani faculty were extremely insightful whereas the guest lecturers from the industry professionals, helped us to correlate the lectures with what exactly happens in the industry. One such guest lecture was on the Quality Management System (QMS) by Mr. Pravin Kulkarni, General Manger, Quality, Biocon Biologics.

He opened the session with a thought provoking question. He asked a simple question, “Why did you choose this field?” After listening to all our reasons, he shared his reasons for choosing this field. He made us realize that well-being of the patients should be our only priority. Patients are the end users of the pharmaceutical industry and patient centrism should be our only approach to step into a career in the pharmaceutical industry.

He had an innovative approach to explain Quality Management System. He initiated a conversation with us discussing about marathons. Little did we know that he would connect with Quality Management System (QMS). He explained the role of QMS in a pharmaceutical company. The onus to develop a culture of quality in the company lies with QMS. It sets policies and procedures required from planning to execution of the product. The process starts right from the initial stage of filing till it is distributed or commercialized in the market and finally reaches our end consumers.  QMS is also responsible for ensuring data integrity which plays a crucial role in achieving a consistent system of quality compliance. He explained the CAPA set by the QMS through an example of the type of shoes used in marathons. The specifications of the shoes should be clearly registered while registering ourselves for the marathon. This is similar to the specifications set by the regulatory bodies during drug filing. In case of any damage caused to/by the shoes during the marathon, measures can be taken to rectify it and prevent it from occurring again. This is required in order to maintain the consistent efficiency of the person running, which is similar to the CAPA taken to rectify the deviations that occur during the product cycle and also ensures that the quality is not compromised.  In the beginning, it was a bit difficult to correlate the example of marathon with pharmaceutical industry but the amazing interactive session by Mr. Pravin helped me have a clear understanding on the role of Quality Management System in the pharmaceutical industry.

His approach was so friendly that our hesitation to ask questions took a back seat.  The entire class participated in asking questions and discussing different situations. The zeal with which he started the session was maintained throughout the session and not for a second, did it feel monotonous or disinterested. Each one of us was engrossed in the discussion to an extent that we lost the track of time. We simply didn’t want the session to end. Apart from the technical knowledge, Mr. Pravin also discussed about his journey and shared his experience of working in the pharmaceutical industry.

He ended the session by telling us that we can reach out to him for guidance not only during our academy days but also in future. Not just the subject, but his friendly & and interactive approach made an indelible mark in my memory.

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MOULY

Written By: Mouly Chatterjee, Applied Industrial Microbiology, Batch VI   

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