Indian pharma industry should work towards creating a sustainable quality culture to remain competitive in the global market, according to a panel of experts.

“The effort to adopt operational quality is crucial. Companies have to integrate good manufacturing practices along with operational quality and process management, stated the experts at a seminar & workshop on ‘Creating Sustainable Quality Culture’ organised by the International Society for Pharmaceutical Engineering (ISPE) Bangalore Chapter.

The day-long event held in mid December focussed on data integrity, quality culture, quality metrics and CAPA (corrective and preventive action).

In his key note address, Raghurama Bhandary, drugs controller, government of Karnataka stressed the need for Indian pharma to work beyond compliance to reach the goal of sustainable quality culture.

S M Mudda, director, ISPE India and chairman, Bangalore Chapter delved on the data integrity issues and stated this was of great concern to both regulators and the industry. “There was a need for the senior management to focus on correcting the underlying reasons on the breach of data integrity.”

R Raghunandanan, chairman, ISPE India Affiliate, spoke on the topic ‘Quality Culture - A way forward’ and  mandated that companies should adopt the same as an organisational philosophy.

Dr Anthony Raj Gomes, sr. vice president- Quality, Global API Operations, Mylan addressed on ‘CAPA and Investigations and called for continuous monitoring of quality systems.

Speaking on ‘Quality Metrics’ AG Raghu, Technical Director, Gland Chemicals stressed the need for measuring the performance quality. “Recent regulations of US FDA focussed on risk-based approach and the possibility of companies being to submit annual report on Quality Metrics.”

The event also organised the felicitation of Dr Divakar Goli, Principal, Acharya BM Reddy College of Pharmacy & Secretary ISPE Bangalore Chapter for being selected as ‘Best Principal of the year2014.’

The day-long programme was well represented by the pharma industry, academia and regulators with over  130 participants being present.