While speaking at the summit, Dr Deo Narain Dikshit, Consultant, Pharma Quality, Compliance and Manufacturing process notified that the expectations of regulatory agencies for compliance with cGMP and other defined established guidelines have been increasing exponentially every year in the past two decades. In addition, new challenges have been appearing for biopharma companies to comply – process performance (2000-2005), data integrity – (2005 till date), elemental impurity –(2015 till date) and nitrosamine impurities – (2019 till date).
Apart from regulatory challenges, there is tremendous pressure on ecosystem of biopharma operations – to meet expectations of quality system in pharma development, product quality and technology life management, management of inspections, operational efficiencies, necessity for adopting automation, newer technologies, data governance and data management, cost efficiencies and productivity management and pressure to meet the demand of product of desired quality at the shortest possible time. Customer focus, quality before cost and employee empowerment are some of the measures to build quality culture, he said.
Dikshit further talked about various measures to build a culture of quality which include customer focus, quality as employee’s responsibility, quality before cost, employee empowerment, continuous learning and continuous improvement, system approach to management, scientific approach, teamwork and integrity, emphasis on prevention, balance between the short and long term, driving out fear, risk management, and giving priority to the individual as well as organisational learning.
He ended his talk by saying that enablers of quality cultures include leadership and vision, mindset and attitude, leading quality indicators and triggers, oversight and reporting and cultural enablers.