March/April 2018


Reining in Consumption for Sustainable Manufacturing

Cover: The word “sustainability” is both overused and abused: We hear about sustainable development in a sustainable economy that uses sustainable packaging for a sustainable future. But it’s an important concept, especially for the pharmaceutical industry as it transitions from manufacturing in stainless steel facilities to single-use technology in much smaller plants. This shift has revolutionized pharmaceutical manufacturing and is producing results that go far beyond the financial.

ISPE 2017 Article of the Year: A Holistic Approach to Production Control

The 2017 Roger F. Sherwood Article of the Year Award winner was originally published in the July-August 2017 issue of this magazine. Written by Prof. Dr. Cristoph Herwig, Christian Wölbeling, and Thomas Zimmer, PhD, it is the first entry in the award’s history in which the judges’ decision was unanimous. The article presents the work of the newly formed ISPE Holistic Production Control Strategy Working Group, which has identified and summarized the need for a redefined control strategy implementation methodology.

Interview with GSK’s Roger Connor

Feature: PE talks with Roger Connor, President, Global Manufacturing Supply, GlaxoSmithKline, whose keynote at ISPE’s 2017 Annual Meeting & Expo made the case for bringing “outsiders” into pharma to jump-start innovative thinking in manufacturing. Jim Breen adds a sidebar about “embracing innovation” and why building facilities of the future is the only way forward.

In This Issue


The United Kingdom's (UK) "Brexit" vote to leave the European Union (EU) by March 2019 has created challenges for the European pharmaceutical industry. Among the first important decisions resulting from the impending departure was where to relocate the European Medicines Agency (EMA), currently headquartered in London. On 20 November 2017, the EU's European Council resolved this concern when...


India is a worldwide leader in drug manufacturing, producing 10% of global pharmaceuticals, with 2016–2017 exports valued at $16.4 billion.1

  • 1RxGPS: The Alliance for Global Pharmaceutical Serialization. "Implementing India's Drug Serialization and Traceability Requirements to Advance Patient Safety and Support Global Trade." White paper, May 2017....

"When a factory is needed in the future, what could it look like, and how should we think and work differently to build it?" This is a question that Roger Connor, President, Global Manufacturing Supply, GlaxoSmithKline, considers frequently. I had the privilege of meeting him during the ISPE 2017 Annual Meeting & Expo. This is an abridged and edited version of our...


Fellow members, it is my pleasure to provide a short update on some of ISPE's accomplishments, its strategic plan, and ongoing activities.


Analytical target profile criteria for judging the quality of results generated by analytical methods are framed in an optimization paradigm by illustrating the ATP criteria as a loss function. In the case where specifications are based on quality arguments and process capability, a probability-defined loss function is useful for providing a direct measurement of risk for making incorrect...


This article shares a process used to evaluate terminal HEPA filter maintenance programs serving a parenteral manufacturing plant. The evaluation determines whether maintenance history data supports extending preventive maintenance frequency.

Terminal HEPA filters in HVAC applications serving Grade B, Grade C, Grade D, CNC, and unclassified areas are...


Great strides are being made in bioprinting, and the end result could revolutionize pharmaceutical development and testing.