July / August 2012 Cover


Managing the Extended R&D Supply Chain
by Petra Bielmeier and Geert Crauwels
This article presents the R&D supply chain and manufacturing operations, from the manufacturing of Active Pharmaceutical Ingredients (APIs) through to the delivery of Investigational Medicinal Products (IMPs) at the clinical site and on to the patient.

The Return on Investment (ROI) of Test Automation
by Stefan Münch, Peter Brandstetter, Konstantin Clevermann, Oliver Kieckhoefel, and Ernst Reiner Schäfer
This article presents a discussion on the considerations around the use of automated test tools vs. manual testing and provides an example of a calculation of Return on Investment (ROI). This article complements and expands on the information contained in the revised GAMP Good Practice Guide on Testing of GxP Systems, which is currently under development.

Harnessing Untapped Information for Enterprise Manufacturing Intelligence
by John Jackiw and Dr. Gilad Langer
This article presents a framework and industry best practices allowing for the definition of usable metrics and intelligence that employ all the available operational data in the organization from the shop floor activities to business operations.

Industry Interview Series: Larry Kranking 
by Larry Kranking 
A longstanding ISPE Member and respected industry leader discusses his vision for Coldstream Laboratories and what it takes for start-up businesses to survive and succeed in today’s market and regulatory environment. Kranking also shares his thoughts on why being a Member of ISPE is important today more than any other time in the history of the industry.

The Use of Acceptable Daily Exposures for Managing the Risk of Cross Contamination in Pharmaceutical Manufacturing
by Stephanie Wilkins and Julian Wilkins
This article presents a convincing justification for the use of Acceptable Daily Exposures (ADEs) to scientifically manage the risk of cross contamination in all types of bio/pharmaceutical facilities.

The Business Benefits of Quality by Design (QbD)
by Theodora Kourti and Bruce Davis
This article presents the results of a survey conducted by the ISPE United Kingdom/Ireland PAT COP.

Rouge: the Intrinsic Phenomenon in 316L Stainless Steel 
by Michelle M. Gonzalez, P.E.
This article will try to demystify the presence of rouge in 316L stainless steel; its unavoidable link with iron; regulatory mandates; detection and monitoring; and the resulting dilemma, removal from or analytical management of process systems.

Applying a Synergetic Approach to Improve Equipment Uptime
by Kevin Pait and Preston Ingalls
This article presents an effective approach of using cross-functional teams to identify and reduce recurring failures through a systematic approach called Total Process Reliability (ToPR) netting a 90% costs savings for the plant.

Overcoming the Challenge of Poor Drug Solubility
by Mitali Kakran, Professor Lin Li, and Professor Dr. Rainer H. Müller
This article was developed from the presentation by a finalist in the ISPE 2011 International Student Poster Competition.

Revision of the Guideline on Process Validation
by Presented by Dick Bonner, Vice Chairman and Director Regulatory Affairs ECA, Advisory Board Member European QP Association
European requirements with regard to Process Validation are in motion with the availability of the new EMA Draft Guideline on Process Validation. The European Compliance Academy (ECA) conducted a survey in September 2011 to evaluate how the European industry views Process Validation. The results were mailed to the EU Commission and the EMA. This editorial summarizes the survey results. Reprinted with permission from the ECA.