November/December 2016

Volume 36, Number 6



Cover: Maurice Parlane, 2016 Max Seales Yonker Member of the Year

Pharmaceutical Engineering sits down with Maurice Parlane to talk about his career, his company, ISPE, and being named 2016 member of the year.

Medreich Limited’s Cutting-Edge Automation System Is a First in India

India’s Medreich Limited adopted a unique and innovative approach to material storage and retrieval at its new facility in Bangalore.


Our first report on quality culture features industry insight on leadership, Gemba walks, the role of behavior, and FDA’s quality metrics research. 


Editor's Voice

Message from the Chair


2016 Member of the Year Maurice Parlane
An interview with Maurice Parlane, Principle of New Wayz Consulting Ltd., New Zealand, and ISPE’s 2016 Max Seales Yonker Member of the Year.


  • ISPE Hosts 2016 Annual Meeting & Expo in Atlanta
  • Women in Pharma Debuts at 2016 Annual Meeting
  • ISPE Guidance Documents: Now Available
  • ISPE Training Institute Courses: February and March 2017
  • Chong Hock Sia Wins Singapore Affiliate’s Special Award
  • Appointments

Member Editorial

FDA Microbiological Policy from the Podium: Formal Guidance Is Overdue
Susan Berlam


Medreich’s Cutting-Edge Automation System Is a First in India

A YP State of Mind

My Letter to 40-Year-Old Me

Young Professionals

Meet Young Professional Caroline Rocks

Career Q&A

Making the Connection

Affiliate Profile

ISPE’s Australasia Affiliate: Dealing with Geographic Isolation


Nuala Calnan introduces Pharmaceutical Engineering’s first report on quality culture, confirms ISPE’s commitment to publish a comprehensive report on cultural excellence, and announces the 2017 ISPE Conference on Excellence in Quality Culture and Performance from 25–26 April 2017 in Bethesda, Maryland.

Shaping Excellence: How Leader Actions and Behaviors Influence Quality Culture
Erika Ballman describes her team’s “Shaping Excellence” interviews with senior quality leaders from across the pharmaceutical and medical technology industries, and discusses the leadership traits, behaviors, and actions they share.

Gemba Walks in the Pharmaceutical Industry: Best Practices and Recommendations from Real-Life Experiences
Margit Schwalbe-Fehl shares insights and best practice recommendations based on real-life Gemba experiences and lessons learned from ISPE member companies.

Leading Indicators of Quality: Pinpointing Behaviors and Measuring Results
Nuala Calnan discusses key insights on the links between culture and behavior, and outlines the role of leading measures of quality in driving desired patient-focused behaviors.

Announcing FDA’s Pharmaceutical Manufacturing Quality Metrics Research
Thomas Friedli, Prabir Basu, and Nuala Calnan review FDA’s recently awarded research grant to establish a scientific base for metrics and integrate quality in operational excellence efforts.


Current Challenges in Implementing Quality Risk Management
James Vesper and Keven O’Donnell

Distribution Quantification of Synthetic Amino Acid Oligomers
Ke Wang, Fangfang Liu, Stéphane Caron, and Kimberly Erland Vukovinsky

Quality Culture Case Study: The Importance of Understanding the Process
Norman Howe and Nicole Leitz


Applying Human Medical Breakthroughs to Our Pets

NOTE: Pharmaceutical Engineering articles are not to be posted on any website, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2016 ISPE. All rights reserved.)

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