May / Jun 2012 Cover


ISPE’s President and CEO: Building Member Value with a Renewed Focus on Regulatory Affairs
Nancy S. Berg reflects on her first 100 days as ISPE’s new leader and summarizes her plans to build Member value and reenergize the Society’s focus on Regulatory Affairs.

Identifying Counterfeit Medicines with Industry-Suitable Technologies
by Dr. Fred Jordan and Dr. Martin Kutter
This article presents the latest pharmaceutical anti-counterfeit technology developments and describes different criteria which will help readers select those that best safeguard patient safety and the integrity of valuable pharmaceutical brands and products.

Risk and Reputation: A Science and Risk-Based Approach to Brand Protection
by Gary E. Ritchie, Emil W. Ciurczak, Sharon Flank, Stephen W. Hoag, and James E. Polli
This article presents an approach that incorporates real time monitoring that can be used as a quality and security measure, by establishing and monitoring a quality threshold.

The Case Against Serialization
by James Robinson, P.E.
This article presents frank and objective reasons why this technology will never be implemented.

Industry Interview Series: Martin VanTrieste, Senior Vice President, Quality, Amgen, and Founder, Rx-360
by Jeff Hargroves, Chair, ISPE Pharmaceutical Engineering Committee, and Rochelle Runas, ISPE Technical Writer
Veteran quality executive Martin VanTrieste provides a snapshot of the global and complex problem of counterfeiting. He explains his passion behind and the creation of Rx-360, an international consortium dedicated to increasing the security and quality of the pharmaceutical supply chain, and his candid thoughts on the importance of collaboration in a competitive industry.

Pressure Pulse Approach for Optimized Tank Cooling after Steaming
by Magnus Stering, Olivier Chancel, and Luc Pisarik
This article presents an approach for faster cooling after steaming or after hot cleaning in place without the risk of generating vacuum inside the vessel and without the need for any large sized vent filter.

Standardization of Single Use Components’ Extractable Studies for Industry
by Ekta Mahajan, Trishna Ray-Chaudhuri, and James Dean Vogel
The purpose of this article is to recommend the formation of a standard(s) for extractables studies conducted on single use systems.