PAT SUPPLEMENT INTRODUCTION


Terry McMahon PAI Partners


THE HISTORICAL DEVELOPMENT OF


THE FDA’S PAT INITIATIVE AND ITS PRESENT COURSE


About a decade ago, although US drug products were uniformly of high-quality, the number of manufacturing-related issues and product recalls appeared to be increasing with possible negative consequences in drug availability and new drug approvals. Starting in 2001, therefore, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation & Research (CDER), began exploring ways of encouraging the use of advanced manufacturing methods, proven in closely related industries, as a vehicle for designing and applying increasingly robust processes through scientific understanding of the reactions taking place. These advanced methods encompassed analytical sensors for assaying the chemical composition ‘on-the-fly’ so to speak, advanced mathematical data analyses to extract more information from existing measurements and related advanced manufacturing technologies.


This program came to be called The PAT Initiative (Process Analytical Technology), with


‘Analytical’ defined broadly and not narrowly confined to chemical composition. In fact, one wag within The Agency observed that the meaning of the program was Process Understanding but ‘The PU Initiative’ just didn’t have the ring to it. The PAT Initiative was strongly endorsed by FDA’s Science Board in April 2002, composed of industry technical specialists, academic researchers and other interested parties that advise FDA on technical matters. The Pharmaceutical Research & Manufacturers Association (PhARMA), the leading industry trade association, similarly endorsed The PAT Initiative. The Senior Vice President for Engineering at an industry leader stressed the importance of raising efficiency levels which should greatly improve


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European Pharmaceutical Review Volume 16 | Issue 6 | 2011


product consistency while lowering overall manufacturing costs. A week after the Science Board’s endorsement, I attended the second PPAR meeting at Pharmacia in Skokie. Frequent references to ‘Ajaz’ prompted my question, “Who is Ajaz?” I was quickly informed that Ajaz Hussain, Deputy Director of CDER, was the main technical driver of the new PAT Initiative and an individual with considerable clout over pharmaceutical manufacturing operations. Dr. Hussain’s initial focus was reviewing the


drug regulatory process with a view to identifying roadblocks to the more extensive deployment of PAT technology. He also organised a special group (the PATRIOT Team) within the Agency’s regulatory apparatus to focus on PAT related issues. In 2003, FDA’s formal PAT Guidance was published and released at the


ACS National Meeting in NYC. At this point, formal attempts to define/describe The Initiative essentially ended and future progress (and it was considerable) would depend on inter - preting the existing guidance. Three professional entities have been most


influential in establishing and sustaining the intellectual infrastructure permitting actual deployment of PAT concepts in pharmaceutical manufacturing processes. In alphabetical order, they are CPAC, IFPAC and PPAR. CPAC – The Center for Process Analysis &


Control at the University of Washington (formerly the Center for Process Analytical Chemistry) is an industry-funded academic research center with twin objectives. Develop useful, relevant industrial technology and professional personnel skilled in these arts. CPAC provided training and orientation for FDA’s PATRIOT Team and the Agency’s reviewers. It continues to serve as an independent technical resource. IFPAC – The International Forum on Process


Analytical Chemistry, now in its 26th year, is the largest annual gathering of process analyser professionals from industry, academia and government. These four day meetings attract a worldwide audience and include plenary presentations on important topics, a high- quality technical program with a strong component of PAT focused sessions, an exhibit


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