November 2015
Volume 39, No. 11 |
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|Focus|
Agnes Shanley
Although shortages, quality, and regulatory challenges remain, improved technologies and new investments suggest that the worst may be over.
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Agnes Shanley
Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.
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|SPECIAL REPORT|
David Keire, Barbara Mulloy, Christina Chase, Ali Al-Hakim,
Damian Cairatti, Elaine Gray, John Hogwood, Tina Morris, Paulo A.S. Mourão, Monica da Luz Carvalho Soares, and Anita Szajek
The global supply chain for bovine and porcine heparin and regulatory considerations are examined.
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PharmTech November Issue
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|FEATURE|
Adeline Siew, PhD
Industry experts share insights on the advances in tablet coating technologies and the potential of continuous coating in solid-dosage manufacturing.
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|PEER-REVIEW RESEARCH|
Carol Rea Flynn, Dan McNerney, and Palak Shah
Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.
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|REGULATORY WATCH|
Jill Wechsler
New program emphasizes quality, risk, and global collaboration.
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Sean Milmo
The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.
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|FORMULATION|
Robert Harris
The determination of topical bioequivalence requires a multi-faceted approach, tailored specifically to the generic-drug formulation.
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|SUPPLY CHAIN|
Robert Celeste
Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.
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|API SYNTHESIS & MANUFACTURING|
Cynthia A. Challener
Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C-H silylation reactions.
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|TROUBLESHOOTING|
Fabian Schapiro
Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.
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|OUTSOURCING OUTLOOK|
Eric Langer
Better process development is creating industry benchmarks for bioprocessing.
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|ASK THE EXPERT|
Siegfried Schmitt
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.
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|VIEWPOINT|
Rita Peters
The CPhI Pharma Awards celebrate innovations in the pharma industry.
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|Webcasts|
On Demand
As global requirements for pharma supply chain safety become more stringent, pharmaceutical manufacturers need to be more proactive in monitoring supply chain partners to ensure security and quality. In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency.
Sponsored by Spectrum Chemical Mfg. Corp.
On Demand
With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.
Sponsored by Mettler Toledo
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