ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
US Food and Drug Administration (US FDA) investigators do not start with the deviation log. They start somewhere else. Most facilities do not know where.
How can pharmaceutical companies achieve inspection-ready digital compliance in the Pharma 4.0™ era? As manufacturers adopt artificial intelligence (AI), connected manufacturing systems, advanced analytics, cloud platforms, and digital quality processes, regulatory compliance must be built into operations from the beginning rather than addressed after implementation....
The ISPE Foundation Professional Development Grant program is designed to help students and recent graduates accelerate their professional growth by participating in premier industry events. Through financial support to attend ISPE conferences, the program provides emerging professionals with opportunities to learn from industry experts, explore the latest trends shaping pharmaceutical...
As the pharmaceutical industry prepares for the introduction of EU GMP Annex 22 on AI, one question continues to emerge:
Driven by a passion for science, problem-solving, and improving patient outcomes, Keira Mull is building a career in pharmaceutical manufacturing centered on continuous improvement and service. As a Senior Manufacturing Specialist at AstraZeneca and an active volunteer with ISPE's Chesapeake Bay Area Chapter, she is committed to operational excellence, mentorship, and professional...
FUJIFILM Biotechnologies’ Galaxy project is redefining how large-scale biopharmaceutical manufacturing facilities are designed, built, and deployed. Recognized with an Honorable Mention in the 2026 ISPE Facility of the Year Awards (FOYA), the facility exemplifies how digital replication, modular construction, and Pharma 4.0™ technologies can accelerate the delivery of critical manufacturing...
This past June at the 2026 ISPE AI in Life Sciences Summit – Powered by GAMP®, I spent time with professionals from across our industry discussing AI, emerging technologies, and what comes next for pharmaceutical manufacturing. Those conversations prompted me to reflect on a topic that was woven throughout the event: innovation and how it happens.
Quality and regulatory teams face a constant stream of external signals: draft and final guidance, inspection trends, revised standards, pharmacopeial updates, and industry commentary. Monitoring these signals is routine; deciding what to do with them is not. The common practice for most companies is to disseminate information broadly regarding updates but apply differing levels of scrutiny...
Scope 3 Sustainability is defined as indirect emissions from an organization's supply chain and operations. Data collection and reporting of Scope 3 emissions within the pharmaceutical manufacturing supply chain is complex and complicated by current regulations, GMP requirements and the diverse geography of suppliers within a global supply chain. The Scope 3 task force within ISPE's...
The 2026 ISPE Annual Meeting & Expo, taking place 18-21 October 2026 in Washington, D.C., USA, will feature one of the pharmaceutical industry's largest gatherings of technology providers, equipment manufacturers, engineering experts, and...
In the first part of this series, we examined the current state of material transfer across cleanroom grades in pharmaceutical manufacturing. Despite rapid advances in automation, the transition between zones of different GMP classifications remains heavily dependent on manual decontamination processes.
Eli Lilly and Company’s Lilly Concord manufacturing facility is redefining what is possible in pharmaceutical project delivery. Recognized with the 2026 ISPE Facility of the Year Awards (FOYA) Operations – Project Execution Category Award, the North Carolina site demonstrates how innovative execution strategies, advanced digital technologies, and disciplined governance can dramatically...
The ISPE Foundation Professional Development Grant program is designed to help students and recent graduates accelerate their professional growth by participating in premier industry events. Through financial support to attend ISPE conferences, the program provides emerging professionals with opportunities to learn from industry experts, explore the latest trends shaping pharmaceutical...
