2020 ISPE Annual Meeting & Expo: Driving the Future of Pharma
Special Reports
2020 ISPE Annual Meeting & Expo: Driving the Future of Pharma
The 2020 ISPE Annual Meeting & Expo will be ISPE’s first completely virtual Annual Meeting. As always, there will be great learning and networking opportunities—in fact, the digital format offers greater flexibility for attendees.
FOYA Category Winners & Honorable Mentions for 2020
Special Reports
FOYA Category Winners & Honorable Mentions for 2020: Examples of Excellence
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year, we added a new category, Social Impact, to recognize companies that developed new standards and practices to prevent drug shortages and increase patients’ access to medicine, designed new tools or techniques that reduced the cost of drug...
How Vaccines Are Developed
Special Reports
How Vaccines Are Developed
Vaccine development is an intricate undertaking, which may involve numerous challenges from the initial process of identifying an antigen to the final steps of delivering and administering the licensed product. The COVID-19 pandemic has put a spotlight on the science of vaccine development. As the world awaits a vaccine for the coronavirus, manufacturers face unprecedented pressure to respond...
Engage with Health Authorities to Mitigate & Prevent Drug Shortages
Special Reports
Engage with Health Authorities to Mitigate & Prevent Drug Shortages
When faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and business continuity plans of drug manufacturers and event-specific actions of health authorities may not always be sufficient to prevent shortages of critical medical products. However, early, transparent engagement with health authorities is a powerful opportunity for drug manufacturers to...
CAPA Maturity
Special Reports
CAPA Maturity
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.
ISPE Pharmaceutical Engineering
Special Reports
Lessons Learned from the Sarbanes-Oxley Act
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 industry today.
Engineer's Role in the Biopharmaceutical Supply Chain
Special Reports
Engineer's Role in the Biopharmaceutical Supply Chain
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 roles engineers play to drive continuous improvement. Part 2, slated for Pharmaceutical Engineering's...
Proof of Closure: Life Cycle of Closed Systems
Special Reports
Proof of Closure: Life Cycle of Closed Systems
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.
2016 ISPE Continuous Manufacturing Conference Summary
Special Reports
2016 ISPE Continuous Manufacturing Conference Summary
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 views of the authors or their organizations.
Young Professional Voices
Special Reports
Special Report: Young Professional Voices
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.