Tag Archive | "Emil Ciurczak"

Can QbD Get Its Definitions Straight?

By Emil W. Ciurczak, Contributing Editor

I have been following a number of conversations on LinkedIn that are driving me to imbibe large amounts of adult beverages. The number of people who disagree on what various terms mean is astounding. For example, we all think we know what PAT means, no? Apparently, no.

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Toy Story: Ciurczak’s Pittcon Picks of 2012

By Emil W. Ciurczak, Contributing Editor

I have only given a brief description of each instrument I found interesting this year in Orlando. The two criteria I used to choose instruments for this review are: 1) is it new (within six months of Pittcon)? and 2) is it a spin on something we have, smaller and better, or completely different? The vendor could be old or new, large or small, but I only ask them to make it interesting.

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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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IFPAC 2012: The Club Opens Up

by Agnes Shanley

Posted in Opinion Editorial, QbD NewsComments (2)

Berlin Conference Discusses QbD and PAT to Ensure ROI

By Emil Ciurczak, Contributing Editor

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