Pharmaceutical Technology, Oct 1, 2008 - Pharmaceutical Technology

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Pharmaceutical Technology, Oct 1, 2008
Articles
Risk Management within the Global Supply Chain
By Sarah Wood , Ronald Dunn , Marsha Nelson , Larry Servi , Susan J. Schniepp
The growth and globalization of the pharmaceutical supply chain make risk assessment more important than ever for pharmaceutical manufacturers. The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.
Compliance in an Outsource Manufacturing Model: What to Look For
By Tim Keutzer , Howard Silver
The authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.
Excipient-Control Strategies
By Irwin Silverstein, PhD , Arthur Falk , Dale Carter, MS , Maria Guazzaroni Jacobs , David Schoneker
Securing the integrity of the excipient supply chain is a crucial task in ensuring the overall pharmaceutical supply chain. The authors outline excipient-control strategies and practices for the manufacture, distribution, and receipt of excipients.
FDA Talks about Supply Chain Challenges
By Angie Drakulich
Pharmaceutical Technology has summarized recent statements by FDA officials on supply chain issues to provde the agency's most up-to-date views and expectations.
Managing Global Change within the Supply Chain
By Karen S. Ginsbury
Regulatory bodies around the world are now revising legislation, regarding counterfeit medicines, good manufacturing and distribution practices, and risk management.
Serialized ePedigree: From Planning to Execution
By Andre Pino
California's ePedigree requirements call for item-level serialization beginning in 2011. The author explains factors to consider when implementing a serialization strategy and how to achieve a positive return on investment.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
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Expedited reviews of drug submissions
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Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
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More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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