One of the main themes to emerge in the CPhI Insights Annual Industry Report is that the pharmaceutical industry needs an evolutionary approach to remain sustainable in the longer term and open up access to drugs to more of the world’s population. Girish Malhotra, President of EPCOT International, argues that for too long the industry has relied on selling its drugs entirely to the developed world and has not focused actively on delivering process innovations that would bring cost savings and increased profits, while opening up new markets in the developing world.
Quality by Analysis stifles innovation and creates ripples of inefficiency in other business areas
He calls for a move away from the current regulation-centric approach towards a more process-centric approach through the adoption of Quality by Design (QbD) rather than Quality by Analysis, which he claims is the cause of innovation paralysis in manufacturing technologies and business practice. ‘This “Analysis Paralysis” approach is already inefficient,’ he says. ‘It stifles innovation and creates ripples of inefficiency in other business areas, including how we manage our supply chains and use capital equipment and other assets.’
Malhotra believes a process-centric approach needs to be embedded within the manufacturing and development process from concept to commercialisation, as this would provide an environment where new innovations are encouraged.
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- Companies:
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- Vision Consulting
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