| ANALYTICS: DATA INTEGRITY |
Amber Lowry
This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.
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| SOLID DOSAGE DRUG MANUFACTURING |
Matthew Billups, Ravendra Singh
A systematic framework and software are needed to implement material traceability in continuous pharmaceutical tablet manufacturing.
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| EXCIPIENT QUALITY |
Cynthia A. Challener
Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.
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| PEER-REVIEWED RESEARCH |
F. Andreas Toba, David A. Miller, Bryan R. Campbell, Debashis Sahoo, James P. Agalloco, Daniel Py
The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
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| QUALITY: MATERIALS QUALIFICATION |
Sade Mokuolu
Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.
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| FACILITY DESIGN AND OPERATIONS |
Jennifer Markarian
Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.
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| ANTICOUNTERFEITING |
Agnes Shanley
While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.
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| FROM THE EDITOR |
Rita C. Peters
Hospitals form not-for-profit drug company to combat drug shortages and high prices.
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| REGULATORY WATCH |
Jill Wechsler
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
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| ASK THE EXPERT |
Susan J. Schniepp
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety.
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