AAPS 2008 Coverage :: QbD for Analytics: The How is Now

Maribel Rios PharmTech editorYesterday I completed my first vidcast at the AAPS Annual Meeting in Atlanta, Georgia. I had the pleasure of discussing quality by design (QbD) as it applies to analytical methods with one of the top experts in this area: Dr. Moheb Nasr, director of FDA’s Office of New Drug Quality Assessment. Read more »

Going Public: NIPTE’s New Design-Space Project

Maribel Rios PharmTech editorOver 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. Read more »

Large-Scale QbD

Maribel Rios PharmTech editorFDA is on its way of getting a boost to its 2009 budget for strengthening its drug-import safety program. Earlier this week, HHS Secretary Leavitt asked Congress for an additional $100 million to improve international safety points, from preapproval testing to postapproval surveillance. Read more »

PAT and QbD Have Many Benefits, but Don’t Bank on Regulatory Relief

drakulich.jpgBrian Stephens, a life sciences consultant for ABB INC, addressed the Interphex 2008 attendees this morning in a discussion about process analytical technology (PAT). He threw out the “learn, predict, control” phrase industry has latched onto as an easier way to define PAT, which is essentially a tool or system for implementing QbD that involves identifying critical quality attributes (CQAs) and critical process parameters (CPPs), and then figuring out the best way to measure the CQAs in order to control the CPPs.

Stephens went on to describe how some 60 FDA investigators are undergoing PAT training this year so they can be better prepared for inspections (and ideally avoid a repeat of the validation inspection process of the 1980s and early 1990s when computer validation came into play). (I find it quite strange, by the way, that FDA has been rolling out and pushing PAT initiatives while still learning about it themselves. Seems like the order of things here is somewhat backward.) Read more »

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