AI and digital tools are shifting quality oversight in the pharmaceutical industry from retrospective testing to real-time, ...

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data ...

In this Q&A with Grace Breen, SVP, Quality, Sharp, we explore the defining moments that have shaped her understanding of what ...

Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in the ...

Quality and reliability are essential in pharmaceutical manufacturing. To ensure compliance and high standards are consistently met, the Installation Qualification (IQ), Operational Qualification (OQ) ...

The pharmaceutical industry is implementing Quality by Design (QbD) and Process Analytical Technology (PAT) more and more, making their symbiotic nature even more obvious. PAT and QbD are catalysts ...

Incorporating sustainable practices into process designs as early as possible ensures optimal performance. Drug developers face increasing pressure to accelerate process development and reduce costs ...

Charles R. Goulding and Andressa Bonafe highlight the shift from clinical pilot programs to everyday pharmacy practice, where ...