| PEER-REVIEWED RESEARCH |
Eric Olson
This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.
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| QUALITY|
Denise L. Miller, Carrie A. Shults, Edward H. Trappler
Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product's lifecycle.
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| DATA INTEGRITY |
Don DiPalma, Jeff Vannest
Integrated computerized systems for data collection improve data security and offer a solution for handling temporary data.
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| BIOLOGICS MANUFACTURING |
Jennifer Markarian
Flow imaging microscopy can be used to identify particulates and their sources.
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| STERILE FILTRATION |
Josh Eaton
PDA reviews an industry survey of concerns and best practices regarding the EU GMP's required PUPSIT test for filters used in sterile filtration.
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| SUPPLY CHAIN |
Agnes Shanley
Demand for direct-to-patient services is exploding. Michael Sweeney, senior director of patient-centric logistics at World Courier, discusses issues that the new model presents.
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| EUROPEAN REGULATORY WATCH |
Sean Milmo
Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.
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| OUTSOURCING REVIEW |
PharmTech Editors
New and expanded facilities point to the continuing growth of the biopharmaceutical industry.
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| ASK THE EXPERT |
Susan J. Schniepp
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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