Pharmaceutical Technology’s Pharma Knowledge Resources Newsletter:
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PharmTech
September 2015
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In This Issue

Build your pharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from bio/pharma industry suppliers.

FEATURED WHITE PAPER

Can You Spot a Fraudulent Calibration Certificate?

Vaisala

It doesn’t happen very often, but recently a customer discovered that one of their calibration certificates was counterfeited. The accrediting body investigated, finding little more than a closed PO Box. The customer had to recalibrate their instruments. Read the story and learn three methods to ensure your calibration certificates are genuine.


Manufacturing

Foaming via Melt Extrusion for Improving the Grindability of Extrudates and Dissolution Rate of Oral Dosages

G. Terife, C. Martin, C. G. Gogos, N. Ioannidis, Leistritz

Significant development efforts are occurring that utilize twin-screw extruder (TSE) technologies as part of unique foam extrusion systems for emerging bioplastics and pharmaceutical products.

Regulations

eMDR is Coming: How to Enhance Collaboration with the FDA

Tim Lozier, EtQ, Inc

In this white paper, learn about benefits and best practices of using the FDA’s eMDR program and best practices of implementing an eMDR system to meet specific business needs.

Analytics

Elemental Impurities per ICH, USP, and EP New Guidelines

Thomas Devadder, SGS Life Science Services

This white paper describes the risk assessment, implementation, and validation of the new elemental impurity guidelines. In order to meet the new standards and provide valid information, ICP-MS will become the standard technology.


Cleaning Validation for Pharmaceutical Manufacturing

Malcolm McLaughlin, Alconox

This paper outlines the basics of cleaning validation and discusses the kinds of support services needed for critical cleaning products in order to optimize your cleaning validation process.

Formulation

Fundamentals of Spray-Dried Dispersion Technology

Amber Broadbent, PhD, Bend Research

Spray-dried dispersion technology is a proven approach to improve the dissolution rate and bioavailability of low solubility compounds, and help bring new medicines to market. This whitepaper will explore the fundamentals of spray-dried dispersion formulation selection, process development, stability, scale-up, and performance considerations.

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