Cover: Delivering pharmaceutical solutions to patients may be more effective with new developments in digital delivery and tracking. This follow-up on a presentation at the 2018 ISPE Annual Meeting & Expo explores some trending solutions.
Feature: To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to assess suppliers of GxP-regulated IT services.
Feature: This article on the digital twin (a virtual replica of a physical entity) launches an ongoing series from the Pharma 4.0 Special Interest Group focusing on key technologies that will modernize pharmaceutical manufacturing and facilitate digital transformation. Pharmaceutical companies use the digital twin to create and model manufacturing processes and enable analysis of how a drug will work inside the human body.
Feature: A group of US FDA panelists responded to a range of questions from 2019 ISPE Aseptic Conference attendees on topics from restricted access barrier systems to smoke studies and artifi cial intelligence.
Feature: This article, the first of a two-part series, looks at challenges that chemistry, manufacturing, and control (CMC) development teams may encounter when a project is given accelerated development status. Key considerations and themes are introduced and future opportunities are explored.
Being on the cutting edge of drug development is the goal of most pharmaceutical companies, but a new drug won’t work if the patient doesn’t take it. It’s a vexing problem that developers of healthcare technologies hope to address.
I’ve been to numerous ISPE conferences in the United States. This was my first ISPE Europe Annual Conference, held 1–4 April, and it did not disappoint! The Young Professionals (YPs) were an integral part of...
Delaware Valley Chapter Executive Vice President Eleanor Small, 34, is a woman with a passion for science and technology. Although still early in her career, she has already accomplished a lot, including being awarded the prestigious Delaware Valley Young Engineer of the Year award for 2019.
ISPE launched its complimentary Pharma Best Practices Webinar Series in April. The debut was outstanding, drawing more than 850 registrants and over 500 real-time participants representing 62 countries...
Many of us have heard of Moore’s Law, named after Gordon Moore, cofounder of Intel1 . Moore’s Law predicted that...
To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to assess suppliers of GxP-regulated IT services.
The Pharma 4.0™ Special Interest Group is focusing on key technologies that will modernize pharmaceutical manufacturing and facilitate digital transformation. These technologies include digital twins, augmented reality, artificial...
The Interactive Regulatory Panel session at the end of the 2019 ISPE Aseptic Conference is one of the most popular conference sessions each year, and the 19 March session at this year’s conference was no...
This article is Part 1 of a two-part series exploring what we can learn from examples of pharmaceutical products being approved using accelerated programs. The series focuses on challenges that chemistry, manufacturing, and control (CMC) development teams may encounter when a project is given accelerated development status. Part 1 introduces key considerations and themes in general terms and...
More than 800 attendees met in Dublin, Ireland, on 1–4 April for the 2019 ISPE Europe Annual Conference—a new record attendance for this conference! Participants at ISPE’s sixth Europe conference learned about...
The ISPE Young Professionals Hackathon, which has become an annual event run in conjunction with the ISPE Europe Annual Conference, brings together some of the brightest, most inquisitive young engineers...
The unavailability of a backup pharmaceutical water system has been a severe limitation for pharmaceutical manufacturers. Until recently, qualification concepts that adhered to current Good Manufacturing Practice (GMP) guidelines hindered the rapid setup of a water system. A new, tailor-made qualification concept for mobile water treatment has been developed to align with guidance from various...
