Thomas P. Garcia, PhD

Pfizer Inc.
Research Fellow, Global CMC
Tom Garcia is a Research Fellow in Global CMC, Pfizer Inc., Groton, Connecticut. He received a B.S. in Pharmacy from Albany College of Pharmacy in 1983, and a Ph.D. in Industrial and Physical Pharmacy from Purdue University in 1989. Prior to joining Global CMC in 2003, Tom spent over 14 years in the pharmaceutical industry in the areas of process development and technology transfer, where his primary interests were powder mixing, blend sampling, and the use of statistical techniques during process development, optimization, and in the assessment of process capability and robustness. He was active in defining regulatory strategies for Quality by Design (QbD) dossiers. Tom is an Adjunct Associate Professor in the Department of Pharmaceutical Sciences at Albany College of Pharmacy and Health Sciences, and held a similar position at Campbell University (1996 – 2000). He was a member of the SUPAC IR Industry Training Committee (1995-1996), served as Chair of the Product Quality Research Institute (PQRI) Blend Uniformity Working Group (2000-2004). Tom was a member of the ISPE Product Quality Lifecycle Implementation Control Strategy Task Team (2007-2010), led the ISPE BUCU Group (2013-2016), and is a co-leader of the ISPE Continuous Manufacturing Group.

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Despite introducing modern analytical technology to assess blend uniformity, many companies are still using traditional blend sampling thieves and wet chemistry to assess blend homogeneity. The use of statistically based sampling plans allows variance component analysis to be conducted on both blend and dosage unit data. This article shows how various combinations of blend and dosage unit...

Holistic Control Strategies for Continuous Manufacturing
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