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Implementing Process Validation Guidances
By Peter H. Calcott, Ph.D., President, Calcott Consulting LLC
Published March 6, 2013
Complying with FDA and EU for small and mid-sized companies Read More »
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 »
Risk Assessment for Single Use Disposable Projects
By Chuck Stock, IPS
Published January 22, 2014
Building quality and value into manufacturing processes Read More »
Patheon
By Kelly Ormsby
With a commitment to quality, scientific excellence and exceptional customer experiences, Patheon is the world's leading provider of contract drug development and manufacturing services. Through an integrated global network of facilities, we give… Read More »
Alliance Medical Products
AMP, a Siegfried Company, provides contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices. Our cGMP, scalable aseptic fill/finish suites support clinical… Read More »
Rottendorf Pharma GmbH
By Rottendorf Pharma GmbH
Rottendorf Pharma is a worldwide operating Technical Operations Organization for development, manufacturing and packaging of solid dosage forms. We offer the complete range of services according to customer needs assuming Total Process Ownership on e… Read More »


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