Pharmaceutical Technology-10-01-2008

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.

The authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.

Regulatory bodies around the world are now revising legislation, regarding counterfeit medicines, good manufacturing and distribution practices, and risk management.

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.

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.

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.