March / April 2017

March 2017 Cover

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Compliance Challenges for a Global Industry

Cover: Amid the great opportunities that flow from extending their networks of facilities around the globe, pharmaceutical manufacturers are facing compliance challenges in emerging markets—especially culturally distinct ideas about safety, risk, and quality.  

The Growing Influence of PIC/S in Asia Pacific

Feature: The Asia Pacific region contains 60% of the world’s population and is the fastest growing region in the world. Of the 24 countries in the region, 19 are being influenced in some way by PIC/S in their regulation of medicine manufacturers.

Sustainability

Special Report: This issue’s special report explores sustainability in the life sciences industry, cleanliness classifications for life science facilities, and the origins of 90 fpm as the standard for cleanroom airflow.

In This Issue

Technical
One of the major changes introduced by the European Union (EU) regulation 536/2014 is an application procedure that will require sponsors to apply for authorization to conduct an interventional/low-intervention clinical trial (CT) via a new EU portal.3...
InTouch
There is still a lot of uncertainty on how to effectively structure a corporate data integrity program. It starts with the definition of the scope and often it ends with parallel work between departments who are owners of different systems along the value chain.
Special Reports
In 1961, while working at Sandia Laboratory in New Mexico, Willis Whitfield and his colleagues developed the world’s first cleanroom and clean benches. These developments were instrumental for the electronics, aerospace, and later, pharmaceutical...
InTouch
There’s an adage that says “the first step in getting anywhere is knowing where you want to go.” That certainly seems to hold true for Japanese Young Professional Takenori Sumi, who not only has mapped out the things he must learn to advance his career,...
Features
The Asia Pacific region, which comprises 24 culturally diverse countries, contains 60% of the world's population and is the fastest growing region in the world today This article describes the growing influence of Pharmaceutical Inspection Co-operation Scheme (PIC/S) in the Asia Pacific region. Of...
InTouch
First and foremost, the authors wish to express their sincere gratitude to the several persons in the US, former or present seniors in the ISPE global organization, and of course the host plants themselves, without whom the 2016 plant tour could not have...
Features
Amid the great opportunities that flow from extending their networks of facilities around the globe, pharmaceutical manufacturers are facing compliance challenges in emerging markets—especially culturally distinct ideas about safety, risk, and quality....
InTouch
Pharmaceutical Engineering consulted ISPE’s new Board of Directors Executives to discuss making a difference, member concerns, objectives for 2017, and their visions for the future. In this issue, we talk to: Timothy Howard, Vice Chair: Vice President...
Insights
The global nature of the supply chain has meant that pharmaceutical manufacturers have to adhere to a hodgepodge of regulations in the diverse regions in which they operate. Efforts to harmonize standards and inspection procedures between countries...
InTouch
Europe Effective and Efficient Deployment of Operational Excellence—Striving for World-Class Performance in Pharmaceutical Operations (T56) 8–9 May Institute of Technology Management (ITEMHSG), University of St Gallen, Switzerland Do you know how to...
Insights
The Pharmaceutical Engineering November-December 2016 editorial, “Collaboration Key in the Quest for Quality,” written by editor in chief Anna Maria di Giorgio, said it well: Collaboration is a strength, and “ISPE members are its ambassadors.” Therein...
Special Reports
Sustainability, also referred to as sustainable development, has, in the pharmaceutical industry, been, in the main, in the background, especially when it comes to facilities and engineering. In the few cases where dedicated individuals or companies have...
InTouch
Unless it’s clear that a graphic is in the public domain or can be reprinted without permission, you should assume that it’s protected by copyright. While most people in scientific and technical fields understand that copyright protection applies to the...
Special Reports
Sustainability And The Life Sciences Industry Sustainability, also referred to as sustainable development, has, in the pharmaceutical industry, been, in the main, in the background, especially when it comes to facilities and engineering. In the few...
Insights
When we discussed assembling this month’s special report on sustainability, the idea of pairing it with an issue on compliance challenges was not an obvious choice. Despite those initial misgivings, the reality is that these two topics are a superb...
Special Reports
In recent years we have observed misunderstanding and confusion over correlation between the 2004 US Food and Drug Administration (FDA) environmental cleanliness requirements for sterile product manufacture 1 and those of the European Medicines Agency...
Insights
Now that we’re all finding smart mentors and career coaches (see the YP State of Mind article in the January-February issue of Pharmaceutical Engineering), I want to reflect on an important skill: perseverance. Engineers and scientists by nature look...