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Published February 27, 2012
Establishing, through documented evidence, a high degree of assurance that a specific process will consistently yield a product that meets predetermined specifications and quality characteristics.… Read More »
Aseptic Process Validation
By Tom Spurgeon
Published November 3, 2006
Is a new FDA guidance imminent? Read More »
By Shamik Pandit
Published August 23, 2005
How the DOE approach can smooth the process Read More »
Hetero USA Inc.
By Paul Sidhu, Vice President
Hetero is the largest privately held pharmaceutical company in India. Hetero is the largest producer of Anti-Retroviral drugs and has 9 FDA-approved manufacturing plants. Hetero’s vertical integration and new facilities, as well as ambition for… Read More »
Samsung Biologics Co., Ltd.
By Gabriel Goroll, Business Development
Situated in South Korea, Samsung BioLogics is a full-service provider for quality-driven CMO services. Our development services include cell-line development, process development, and analytical services (characterization, comparability, IPC, lot rel… Read More »
By Kenneth Drew, Ph.D., Director, US Sales & Business Development
Six Steps to Qualifying Disinfectants
By Deborah Ensign, Microtest Laboratories
Published January 22, 2013
Test methods, validation and more Read More »
By Jared Hahn, Marketing Manager, Business Development
By Phill Dritsas, President
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