Panel Discussion: From compliance to competitive edge: Making quality the cornerstone to success
At the recently held PLI Conference 2025, an insightful discussion on the significance of quality in the pharma industry was held. The panel titled “From compliance to competitive edge: Making
quality the cornerstone to success,” was moderated by Dr Ranjit Barshikar, CEO- QbD International, United Nations Advisor, QbD/CGMP Consulting and included quality leaders like Gopi Reddy, VP-Corporate Quality, Sun Pharma; Dr Madhu Raju Saghee, VP – VP-Corporate Quality (Global Injectables), Lupin; Minoo Biju, Head-Regulatory Affairs, Piramal Pharma; Manoj Chitnis, VP-Corporate Quality, JB Pharma; and Tripti Nakhre, VP-Regulatory Affairs & Packaging Development, FDC.
The discussion began by highlighting the importance of the right leadership inorder to imbibe the right quality culture within a company. The panellists agreed that leadership should be forward-thinking, embrace innovation while ensuring decisions are free from bias and driven by objective analysis to build a culture of quality.
They also highlighted that a responsible leader advocates a culture of accountability across teams, not only upholding high standards but also embedding a culture of continuous improvement and excellence within the organisation.
The panellists stressed quality must be a core-value for pharma companies. They also underscored that quality is an inter-dependent system, so it is pertinent to all the departments of a pharma firm.
The role of AI in implementing a robust quality management system and driving innovation within the industry was the next point of discussion. All pharma companies are becoming digital factories. So the pharma workforce must also upskill and reskill to keep pace with the transformations.
Implementing smart and new technologies that can ease daily tasks or monitor crucial areas such as reading software that aids in understanding new guidelines/compliances, ChatGPT based SOP, STP software making information accessible, camera-based AI model that monitors cleanrooms were also discussed during the session.
The quality experts also discussed various automation techniques and technologies that can ensure quality to be held in the highest regard from R&D to commercialisation. They accentuated that implementing a quality by design approach from the development stage of a product can result in creating a procedure that is designed to uphold regulatory guidelines and maintain quality standards while simultaneously simplifying the process throughout a production cycle. They also discussed the importance of training the workforce to empower them with skills needed to keep pace with the transformations in the industry.
They also discussed on several types of monitoring technologies for track and trace to protect the product from tampering or counterfeiting and softwares that can monitor and process data of the efficacy of the product once launched to encourage pharmacovigilance practices can aid quality control overall.
Thus, it was a comprehensive discussion on quality and the strategies to achieve and uphold it across teams and functions in pharma organisations.