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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 »
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
The establishment of documented evidence (for example, data derived from rigorous testing) that provides a high degree of assurance that a specific process or system will consistently yield a product meeting predetermined specifications and quality a… 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 »
By Abbey, Whitney
Lyophilization Technology, Inc.
By Edward Trappler, President
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By Gil Roth
Published December 2, 2013
Manufacturing validation step pushes review date for hemophilia B treatment Read More »
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