Tag Archive | "IFPAC"

Memoirs from IFPAC 2012

By Emil Ciurczak, Contributing Editor

Sunday, January 22, 2012

Posted in Expert Insights, QbD NewsComments (0)

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.

Posted in QbD NewsComments (1)

IFPAC 2012: The Club Opens Up

by Agnes Shanley

Posted in Opinion Editorial, QbD NewsComments (2)

Baltimore Bound: Looking Ahead to IFPAC 2012

The annual IFPAC conference has become one of the more fruitful events for those wishing to stay on the cutting edge of process analytical technologies and Quality by Design. IFPAC is now promoting its 2012 event (see press release below), and we’re glad to help get the word out.

Posted in QbD NewsComments (0)

QbD Tools: LIF Makes a Comeback, While Enhanced Imaging is Emphasized at IFPAC 2011

By Agnes Shanley

The International Forum for Process Analytical Technology (IFPAC) is often seen more as a networking event for those working on PAT and QbD, rather than a groundbreaking conference displaying radical innovations.  Last month, IFPAC 2011 in Baltimore brought some of the same old presentations, but also a few surprises, including an emphasis on biopharmaceutical PAT and more practical case studies showing what is, rather than what may, be done with PAT and QbD.

Posted in QbD NewsComments (3)

Staying Within the Lines? Interpolation vs. Extrapolation in the Design Space

By Agnes Shanley

A presentation at IFPAC last Thursday brought on some heated debate about the Design Space, and  just how dynamic it can, or should, be.  Should any changes due to unanticipated “real world” situations necessarily trigger the development of a new design space, and post-approval change filings and more testing?

Posted in QbD NewsComments (0)

Page 1 of 212