Tag Archive | "Merck"

Memoirs from IFPAC 2012

By Emil Ciurczak, Contributing Editor

Sunday, January 22, 2012

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Sampling at IFPAC: Will Pharma Move to Large N?

by Agnes Shanley

The GMP code requires that manufacturers run a “statistically significant” number of tests on product, and assumes that they maintain control over their processes. However, in practice, testing of batches is currently between 10-30 samples. As more drug manufacturers implement at-line, online or inline process analyzers, the number of tests run could potentially increase dramatically.

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Snippets from AIChE: Navigating QbD’s Shades of Gray

Last Wednesday at AIChE 2011 in Minneapolis, speakers from FDA and industry joined in a Round Table discussion on Quality by Design regulatory filings. What follows are some snippets from the open forum. Among the questions raised: Do we really need to distinguish between a QbD and non-QbD filing? How do we get upper management on board for QbD? How do chemical engineers get regulatory professionals believing in a QbD approach?

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Envelope Please: AIChE Hands Out QbD Awards

In Minneapolis on Tuesday night, Joe Hannon, CEO of Scale-up Systems (DynoChem), noted how the Quality by Design track at this year’s AIChE annual meeting in Minneapolis was “more like going to M.I.T. than Las Vegas”–substance over glamor, in other words.

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Merck’s Integrated QbD Approach: Patient-Focused and Bringing Manufacturing Closer to Development

By Paul Thomas, Senior Editor

At AIChE 2011 in Minneapolis yesterday, a team from Merck discussed the approach the company has taken to better integrate QbD work among drug substance and drug product teams, and across the organization in general. The talk was part of the inaugural AIChE Excellence in Integrated QbD Practice Award session, chaired by Eric Ahuja and John Lepore, two of the leaders at Merck in advancing QbD. (We’ll have more on the award winners in the coming days.)

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America’s Top Modelers: Accelerating Pharma Process Development

By Paul Thomas, Senior Editor

This week in Rosemont, Illinois, DynoChem software (from Ireland’s Scale-Up Systems) hosted its annual North American user group meeting. User groups are wonderful opportunities to learn what’s really happening behind closed doors at leading companies. At the DynoChem meeting, chemical engineers and modeling experts from Eli Lilly, Abbott, Pfizer, Merck, GSK, Amgen, and other major manufacturers shared details of their current advanced process modeling.

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