Special-Reports

Special Reports
This special section looks at what’s coming up at the 2019 ISPE Annual Meeting . It also features the voices of first-year Travel Grant recipients who attended last year’s Annual Meeting courtesy of the ISPE Foundation and offers a look at the 2019 Facility of the Year Award (FOYA) category winners...
Special Reports
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program . This year’s nine category winners and honorable mentions range from industry giants with hundreds of years of history to relatively new enterprises....
Special Reports
The ISPE Foundation ® awarded 14 Student Travel Grants to bring 14 students to the 2018 ISPE Annual Meeting & Expo . Investing in the next generation of pharmaceutical engineers is a goal of the Foundation, which was formed in 2018.
Special Reports
The 2019 ISPE Annual Meeting & Expo will be held 27–30 October in Las Vegas, Nevada. The theme is “Modernize. Globalize. Transform.” Michael L. Rutherford, Program Committee Chair and Board Ambassador for ISPE, and Executive Director for Computer Systems Quality and Data Integrity at Syneos Health,...
Special Reports
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program . This year’s nine category winners and honorable mentions range from industry giants with hundreds of years of history to relatively new enterprises....
Special Reports
More than 800 attendees met in Dublin, Ireland, on 1–4 April for the 2019 ISPE Europe Annual Conference —a new record attendance for this conference! Participants at ISPE’s sixth Europe conference learned about how manufacturers, key suppliers, functional peer groups, and regulators expect the...
Special Reports
Digitization, Technologies, and More at 2019 ISPE Europe Annual Conference More than 800 attendees met in Dublin, Ireland, on 1–4 April for the 2019 ISPE Europe Annual Conference—a new record attendance for this conference! Participants at ISPE’s...
Special Reports
The ISPE Advancing Pharmaceutical Quality (APQ) team is developing a framework by which a company can assess its maturity in relation to quality culture, operational excellence, and ICH Q10 elements, using the CAPA system as the focus of the pilot.
Special Reports
Sold-Out Europe Annual Conference Draws Record Attendance In March 2018, more than 640 attendees met in Rome for the 2018 Europe Annual Conference.The record attendance and roster of 70 speakers made it the largest ISPE Europe meeting to date. Sessions...
Special Reports
The smart factory, the factory of the future, the Industrial Internet of Things (IIoT), and Industry 4.0. These are buzzwords that populate a new manufacturing world triggered by digitalization. “Pharma 4.0” is a holistic operating model for...
Special Reports
  Deadlines Are Looming Whether serialization deadlines have arrived or are imminently approaching, smaller companies along pharmaceutical supply chains are scrambling to prepare—and for many, it’s a problem. Making a Serialization Program...
Special Reports
Whether serialization deadlines have arrived or are imminently approaching, smaller companies along pharmaceutical supply chains are scrambling to prepare—and for many, it’s a problem. TraceLink, a track-and-trace network for pharmaceuticals, estimates...
Special Reports
Fifteen years ago, corporations embarked on a journey toward SOX compliance; along the way they have learned a tremendous amount about data integrity as it relates to financial systems. Those lessons learned are directly applicable to many of the data-integrity challenges facing the pharmaceutical...
Special Reports
Data integrity continues to be a very hot topic for both regulators and the pharmaceutical industry. With the increased observations about data integrity in laboratories, could it be that analysts have changed how they do science in the laboratory? Are...
Special Reports
Before the advent of integrated computer systems, LIMs, HMI interfaces, comprehensive software, CGMP, BAS, process control systems, PAT, and the use of statistics, manual record keeping was fraught with errors—most of them unintentional. This led to...
Special Reports
ISPE Proposes an Advancing Pharmaceutical Quality Program The ISPE Quality Metrics team has proposed an industry-led approach to advance pharmaceutical quality beyond the submission of data for three harmonized, reportable metrics: the Advancing...
Special Reports
China’s biological pipeline may take the lead China and India have demonstrated their capability in good manufacturing practice (GMP) manufacture of small-molecule drugs for decades. But...
Special Reports
The portfolio sold by today’s global biopharmaceutical industry is fundamentally different than it was even a decade ago. This shift is a reflection of today’s global market, which features greater competition, more treatments for orphan diseases, an...
Special Reports
As the industry evolves in its quest to increase quality, productivity, efficiency, and safety, engineers must be equipped with skills that enable them to meet new and challenging demands. This first in a two-part series focused on biopharmaceutical manufacturing explores a few of the exciting...
Special Reports
This article was developed by members of the ISPE Biotechnology Community of Practice. The views and opinions are those of the authors and do not necessarily reflect the official policy or position of Hargrove Life Sciences, M+W, Novartis, Sandoz, Takeda, or any of their officers.
Special Reports
This paper discusses the findings and outcome of the ISPE Continuous Manufacturing Conference held 20–21 April 2016 in Baltimore, Maryland. While the ideas captured below reflect presentations and discussions both during the main conference and in breakout sessions, they are not necessarily the...
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...
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...
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...
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...
Special Reports
ISPE knows that the future of the pharmaceutical industry lies with its youth—and to prove it, we’ve contacted five former contestants to see how the competition affected their careers.
Special Reports
North and South America Argentina Affiliate Brazil Affiliate Canada Affiliate (11 winners) US Affiliate United States (151 winners) Boston Area Chapter (Massachusetts, Connecticut, Rhode Island, Maine, Vermont, New Hampshire, and Upstate New...
Special Reports
In 2007, Karthik Ramachandran graduated from the University of Colorado in Boulder. His graduate studies brought him to the University of Kansas, where he found himself engaged with the school’s Institute for Advancing Medical Innovation. Since then...
Special Reports
I’m a pharmaceutical professional, toxicologist, project manager, validation specialist, wife, mother, and daughter. I did not get where I am in my career without the support, wisdom, and mentoring of others. My mother, who majored in math and minored in...
Special Reports
For eight years I’ve attended ISPE educational sessions across the country, from Kansas City and Saint Louis to Chicago, from Atlanta and Baltimore to San Diego and San Francisco. I’ve learned...
Special Reports
As I walked up to the Atlanta Marriott Marquis, the magnitude and grandeur of the building set the stage for how much bigger this ISPE event was than any business event I’d previously attended. The atrium was packed to the brim. There were polished...