Dr Ranjit Barshikar’s session was a testimony to his rich and varied experience in the pharma industry, especially in Quality Management, R&D, Mfg.-US FDA / EU / WHO etc. compliances. Speaking on the topic, ‘QbD: Lessons learned, challenges and opportunities’, he highlighted how QbD is a systematic, knowledge and risk-based activity customised for pharma, he informed that it is the new quality system that replaces current GMP concepts. He also informed that it involves focus on patients and products, science and risk-based approach, and continuous improvement, among others.
Elaborating on various issues that Indian pharma industry faces such as quality, lack of efficacy, product recalls and drug shortages, he accentuated the need for QbD to tackle these challenges and assure good quality for sustained success in the pharma industry. He also detailed the various regulatory challenges that arise after companies submit their documents and briefed the audience on the various measures taken by renowned pharma firms to deal with them.
He went on to assert the need for quality and advised building a harmonised pharma quality system across the lifecycle of the product. He said that we need a fundamental shift in our technical skills and mindset about design, manufacture and control to establish a culture of quality across the organisation. He ended the session by highlighting the advantages of QbD such as patient safety, scientific understanding of process and methods, robust product/ process development, right first time, cost savings, improved productivity and transparent operations.