Please give everyone associated with the pharmaceutical industry the wisdom, creativity and simplicity to apply science, common sense and imagination so that we can create processes, both for API production and formulation,  that are right the first time, and so that we no longer have to analyze intermediate samples.  In other words, they’d be true ”quality by design” processes from the start.

One way to do this would be to break down some of the silos that prevent so many manufacturers from improving product quality.

How about having one person oversee three departments that must be aligned for quality and continuous improvement to take place.  These would be:  Process Engineering, Quality Assurance and Regulatory Affairs.

A fine chemicals company that I used to work for did this in the past, and we saw tremendous improvements in a very short time.

Having direct oversight of these critical areas, and allowing equal opportunities for input from each, would be the best way to optimize processes and products, and achieve true quality by design.

So, Santa, maybe you could put a bug in some pharma CEO’s ear, and we’d see one Big Pharma company pilot something like this next year?  Too late for Pfizer, but J&J, maybe?

Bless us, every one,  with common sense and science.

–Girish Malhotra

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