The future of the pharmaceutical industry is being shaped by rapid advancements in digital technologies, automation, and data analytics. As we look ahead to 2025, the concept of Pharma 4.0™ is no longer just an aspirational vision—it is becoming a transformative reality that will redefine how medicines are developed, manufactured, and delivered to patients.
Lindsey Daniel, Director of Product Operations Strategy and Business Lead at Takeda, is an exemplary champion for and beneficiary of ISPE. Daniel embodies leadership and collaboration in numerous ways: as a mentor, mentee, friend, colleague, mother, and more. With over 12 years of active involvement with ISPE, she has served on various committees, including ISPE’s International Women in...
In the pharmaceutical industry, ensuring the safety, quality, and efficacy of products is paramount. With the increasing complexity of manufacturing processes, the growing reliance on computerized systems and advancements in technology, GAMP® guidance provides a framework for validating and maintaining the integrity of computerized systems, ensuring they are fit for their intended...
The presentation by Ian Deveau, PhD, from the US Food and Drug Administration (US FDA) Office of Compounding Quality and Compliance at the 2024 ISPE Annual Meeting & Expo on 15 October 2024 provided an in-depth look at the US FDA’s perspective on drug compounding, its regulatory framework, and the significant events that have shaped current practices. Here is a summary of the key points...
Every dose of medicine represents a promise of quality—a commitment to safety, efficacy, and availability for the patients who depend on it. At the 2024 ISPE Annual Meeting & Expo, Jennifer Maguire, PhD, Director of the US Food and Drug Administration’s (US FDA) Office of Quality Surveillance (OQS), outlined how the agency is transforming its approach to pharmaceutical quality surveillance...
At the 2024 ISPE Annual Meeting & Expo, a session focused on lifecycle management considerations for cell and gene therapy was held. This session invited experts in their field to review...
