Article | February 24, 2014

QbD: Lessons Learned From An FDA Filing

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By Trisha Gladd, editor, Pharmaceutical Online and BioProcess Online
Follow Me On Twitter @pharmaonline and @bioprocessol

Trisha Gladd

Implementing quality by design offers not only a proactive approach to product development, but also the opportunity to streamline your filing process.

Whether you’re a well-established pharmaceutical company with more than 50 years of experience, or you just opened your doors last week, completing your first quality by design (QbD) filing with the FDA is going to be a challenge. After all, if it were easy, everyone would be doing it. QbD promises a more efficient manufacturing process, with quality and safety you can count on every time. Who wouldn’t want that?

The problem is it isn’t easy, and with the FDA not mandating the systematic approach of QbD, many haven’t veered from their current filing processes. But with so many benefits of using QbD — getting your drug to market quicker, reduced recalls and rejects, minimized post-approval changes — it may be time to start considering the change. The team at Ash Stevens, a fullservice pharmaceutical CMO, learned that implementing QbD does require a significant investment of time and money. Nevertheless, the end result is a more well-defined and carefully planned manufacturing process.

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