Over the years, I’ve heard several pharma industry members point out the catch-22 of seeking the advice of experts at agencies such as FDA and USP. These agencies hire some of the most well-respected experts in their field, however, when they are speaking as FDA or USP officials, they must be careful to stick to the agency script and may be somewhat restricted into providing only what has been “approved” to say. I’ve attended conferences in which the moderator will start off saying, “speaking as a (USP, FDA, etc.) officer, I can only say…” and so on. This may be necessary in front of a large audience, of course, but can also be a hurdle for real information sharing.
A discussion I had this week with Dr. Prabir Basu, executive director of NIPTE (the National Institute for Pharmaceutical Technology and Education), made me feel more at ease about this situation. NIPTE was recently awarded a $1.9 million grant to start a two-year project that would use quality-by-design principles, including design space, in manufacturing unit operations such as blending, granulation, and drying, and relate this information to scale-up and stability.
There was a major condition to the grant: the information gained from the project had to be made public. As a not-for-profit organization, NIPTE agreed and hopes to hold an open workshop about their results around September 2010.
And so, this organization comprising the cooperation of 11 universities is getting a good start into providing the knowledge the industry’s manufacturers desperately crave. The real-world process details involved in QbD, design space, scale-up, and stability have a close tie to product safety and the quallity of public healthcare, as Dr. Basu observed. Industry has debated for some time what these terms meant, it is now time to move on to answering the question of “How?”