Take the 2007 American Association of Pharmaceutical Scientists meeting. Despite the numerous, jam-packed quality-by-design and process analytical technology sesssions, I kept hearing disgruntlement from attendees: "Why do we have to change our entire system if FDA is not changing the way it does inspections?" "If we provide FDA with more detailed information, that will open the door to more questions—and perhaps less approvals." "I agree with QbD, but the higher-ups won't pay for it until there are proven results (i.e., revenue)." "Quality systems and harmonization are not required—so why follow them?"
Another common concern had to do with the global impact on the pharma industry. If a company finalizes its design space, for example, and then decides to contract out a few steps, different regulations in different countries throw a wrench in the whole based, risk managment" plan.We'd like to hear your thoughts on these issues, so please email [email protected]
Stay tuned for more PharmTech Talks. Angie Drakulich is the managing editor of Pharmaceutical Technology.
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