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Packaging Validation: E&L Detection
By Kurt L. Moyer and James R. Scull, NSF Health Sciences
Published November 13, 2013
Improve patient safety and avoid costly product-launch delays Read More »
Published July 13, 2013
R&D experts explain why particle size analysis is of paramount importance in pharmaceutical product development and why light scattering and optical microscopy methods are typically employed for particle size analysis in drug development and qual… Read More »
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 »
By Makarand (Mak) Jawadekar, Contributing Editor
Published May 30, 2012
Light Induced Fluorescence Technology Read More »
Aseptic Processing Validation
By Ross Acucena and Randy Wilkins
Published April 4, 2012
Best practices for sterile filtration validation of re-use and extended-use processes 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 »
Published February 27, 2012
Validation batches are commercial scale batches that are manufactured consecutively in order to validate a process according to a validation protocol that was developed and authorized.… Read More »
Is Three-Batch Validation Obsolete?
By John Avellanet
Published September 1, 2010
Where is the new process validation guidance leading us? Read More »
Aseptic Process Validation
By Tom Spurgeon
Published November 3, 2006
Is a new FDA guidance imminent? Read More »
Published September 16, 2014
Adds serialization for labeling and encoding, updates ops Read More »
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