When FDA first published its visionary paper on 21st Century Initiatives, it's purpose was to give direction to the innovation in technology and management for fully (current) grown pharmaceutical industry. Besides this, the other initiatives which FDA and other regulatory agencies have taken, namely PAT, risk based approach and defining quality systems in GMP prespective are all moving in the same direction of innovation and gives logical interpretation of quality systems management. Though much of it has been said, but nothing substantial has moved on the floor - particularly in India!
ICH is primarily engaged in integrating the current global pharmaceutical quality and related philosophies and practices. However, the newly published ICH Q9 and Q10 speaks of something which was already existing into the innovation hungry pharmaceutical industry. The application of 'risk assessment' and 'quality systems' do not offer anything new. My view point on these developments is this, that it is almost a decade after the advent of 'International GMPs' in India, there is nothing new which is emerging. The cross-functional reviews and the system controls like - Change Control, Incidents handling, APQR and CAPA are still living their life to full.
I don't remember any regulatory inspector asking for the risk assessment details for any drug development process till its commercial launch!
The FDAs 21st century approach and PAT also emphasise on automation and innovation, but nothing substantial has really moved on these fronts at least in India. There appears few seminar brochures giving details on discussions on these topics, few articles appearing in prominent international journals - but nothing beyond that. I am not so sure of European and American companies for imbibing PAT into their regular practices.
The same is the fate of Six sigma or Lean management for pharma industry. We live with the concepts and when the implementation comes - we wait for the regulatory compulsions to arrive.
The question here is - why so many thoughts but no applications ? Have we reached the saturation in terms of implemneting quality systems? Does too much of expectations are distancing the innovation ?
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