Pharma, QbD and Bikash Chatterjee’s “Argument for Change” in FDA and Industry

In our next issue, Bikash Chatterjee, president of Pharmatech consultants, USP advisor and president elect of ASQ's Northern California chapter responds to an article we'd published in April on FDA's move to become more scientifically-driven.  It's a must-read; watch for it in June's issue.  Below, a brief excerpt "In my 25 years as an industry professional I have seen many sound initiatives come and go;  JIT, TQM, QFD all failed to gain traction with [pharmaceutical] quality organizations.  Throughout this period the agency's response to the escalating drug complexity and associated public safety issues has been to step up the level of regulatory oversight. Consequently, the addition of risk-based cGMP guidelines for the 21st century has sent the industry reeling. Can we reconcile our history of controlling product safety through heightened quality oversight and incorporate these new scientific characterization requirements? Unlike previous failed initiatives that inhibited operational process innovation, the de facto consensus determined by the ISO, ICH and FDA swiftly validates the new risk-based approach as best practice. So why has our industry, which has prided itself as being scientifically driven, struggled with the concept of QbD? Why has PAT not become the ultimate business trump card? Although Big Pharma and Biotech are beginning to embrace these redefined basic principles of process characterization and variation control, the remainder of the industry remains largely uncommitted. Lean Six Sigma initiatives are creeping into process improvement programs but have yet to propagate to the R&D phases of the drug lifecycle. I believe the problem lies in two places: Our motivation"”or lack thereof"”as  an industry for change, and secondly in the fact that much of the significance of the new initiatives lies at the characterization of process at the R&D stage, a place that traditionally has little regulatory visibility..."
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  • <p>Bikash Chatterjee’s upcoming note is going to echo the sentiments that I have written about and expressed repeatedly. The change is coming and fast but many are naïve or that it would not happen and consider pharmaceuticals are invincible.</p> <p>Every pharma process I have been involved with is “a large labâ€? but on few hundred multiples of the lab equipment. It is sad that chemists and chemical engineers are not practicing simplicity that has been taught to us. Conversions are low and the processes are uneconomical on a "specialty chemical" basis. The only reason, the pharma is able to sell the "specialty chemicals that have a disease curing value" is as we want to extend our life and will pay anything for it. Thus, the process inefficiencies are tolerated and this makes selling a pharma profitable. If life extension is taken out of the equation, Pharma companies would be out of business fast.</p>

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  • <p>Bikash Chatterjee’s upcoming note is going to echo the sentiments that I have written about and expressed repeatedly. The change is coming and fast but many are naïve or that it would not happen and consider pharmaceuticals are invincible. <a href="http://www.tipsondatings.com/beginning-new-relationship.html">beginning a new relationship</a> </p>

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