While attending the second Pharmaceutical Process Analysis Roundtable (PPAR-2) in 2002, hosted by Pharmacia in Skokie, EL, frequent references to "Ajaz" caused me to inquire: "Who is Ajaz?" The response was Ajaz Hussain, Deputy Director of the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and the prime proponent of the Process Analytical Technology (PAT) Initiative. Thus began my introduction to the FDA's foray into pharmaceutical manufacturing technology. My introduction to Quality by Design (QbD) began at an International Forum on Process Analytical Chemistry (EFPAC) meeting a year or two later. In the years since, I have followed these initiatives closely and commented on them frequently in my columns.
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