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..."
