Special Reports

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
  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
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
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
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
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
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...