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Last Updated Monday, October 20 2014
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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 »
Oh Grow Up! Analytical Methods in the Age of PAT
By Emil W. Ciurczak, DoraMaxx Consulting
Published May 1, 2014
Guidances developed for chromatography may not work for Process Analytical Technology. Don’t wait for them to catch up; use other methods. Read More »
Globepharma, Inc.
By Dr. Sanni Raju/Melissa Herko
GlobePharma, Inc., celebrating 20 years, specializes in solid dosage form equipment and formulation development lab services. Our product lines include all Scale Portable Blenders, rotary tablet presses, instrumentation, unit dose/bulk powder (with c… Read More »
Published October 16, 2013
Expands capabilities in the region Read More »
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