All opinions are my own.

Friday, December 22, 2017

Pharmaceutical Manufacturing Technology Innovation: Does Reading the Tea Leaves Matter?

For the last few years I have been presenting my perspective of where, how and why pharmaceutical industry as well as the regulators need to review where the collective is and could/should consider to make the drugs affordable to significantly large (may be 60%) population of the global population.

I often go back and review my experiences and perspective that I have presented over the years to see if we are making headway in technology innovation that could or would drugs more affordable.

Following are some of the old blogs.  

  1. Process Centricity is the Key to Quality by Design Tuesday, April 6, 2010 https://pharmachemicalscoatings.blogspot.com/2010/04/process-centricity-is-key-to-quality-by.html
  2. Why Fitting a Square Plug in a Round hole is Profitable for Pharma and Most Likely Will Stay? August 1, 2014  https://pharmachemicalscoatings.blogspot.com/2014/08/why-fitting-square-plug-in-round-hole.html
  3. Are The Rules A Constraint to Innovation, Competition and A Cause of Adulterated Product? October 1, 2010  https://pharmachemicalscoatings.blogspot.com/2010/10/are-rules-constraint-to-innovation.html
  4. Reading the Tea Leaves: Predictions for Pharma's Future Original January 14, 2014          https://pharmachemicalscoatings.blogspot.com/2016/01/reading-tea-leaves-predictions-for.html
  5. Pharmaceutical Companies Can Innovate If They Want To, October 15, 2010  https://pharmachemicalscoatings.blogspot.com/2010/10/pharmaceutical-companies-can-innovate.html
  6. Regulatory Compliance vs. Operational Excellence: What Should Happen First? February 3, 2015 https://pharmachemicalscoatings.blogspot.com/2015/02/regulatory-compliance-vs-operational.html 

It is interesting that in the last few years “continuous manufacturing” like acronyms QbD and PAT have become the latest buzzword in pharma. US FDA has introduced these terms to be adopted as if they will solve all the quality issues and as if the companies have designed operations using matchsticks. Companies have to address their issues rather than regulators suggesting what the companies need to do. Companies innovate manufacturing technologies and regulators don’t, they just regulate.

Reading the tealeaves is generally related to what the future holds. I consider it voodoo or an exotic past time. If we do not act on our needs/desires to achieve our goals, someone reading tealeaves for one’s future does not matter. What matters is self-actualization (1) at every company. Outside influences do not matter much if we do not internalize excellence. 

I have conjectured it my most recent blog “Innovation In Pharmaceuticals: What Would It Take & Who is Responsible?” that innovation has to be internalized and cannot be thrust by any external body especially the regulators. “Process Centricity” has to overtake the current “Regulation Centricity” in pharmaceuticals and that is the only way to achieve consistent product quality and make drugs affordable.

  1. Self-actualization: https://en.wikipedia.org/wiki/Self-actualization, Accessed December 22, 2017

Girish Malhotra, PE
EPCOT International