July / August 2019

Pharmaceutical Engineering July/August 2019 Cover

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Improving Pharmaceutical Connections with Patients

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.

Application of the Soc 2+ Process to Assessment of Gxp Suppliers of It Services

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.

The Digital Twin: Creating Efficiencies in a Virtual World

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.

2019 ISPE Aseptic Conference: Interactive Regulatory Panel Addresses Multiple Aseptic Issues

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.

Accelerated Pharmaceutical Product Development, Registration, Commercialization, and Life Cycle CMC Lessons, Part 1

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.

In This Issue

Features
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.
Insights
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 the conference in Dublin; they led tracks, hosted and participated in the ISPE Europe...
InTouch
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.
InTouch
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 and six regulatory agencies from around the world.
Technical
In this article, a new method for the analysis and comparison of dissolution profiles is proposed and illustrated with case studies. This useful strategy makes effective use of dissolution profile data by using all data in each profile to create two...
Insights
Many of us have heard of Moore’s Law, named after Gordon Moore, cofounder of Intel 1 . Moore’s Law predicted that computing would increase in power and decrease in relative cost at an exponential pace. This allows us to use this power for new technologies such as machine learning and artificial...
Features
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...
Features
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 intelligence, big data and analytics, mobiles, cloud, advanced...
Special Reports
Digitization, Technologies, and More at 2019 ISPE Europe Annual Conference 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...
Special Reports
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 how manufacturers, key suppliers, functional peer groups, and regulators expect the...
Special Reports
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 from across Europe for a two-day networking and learning event.
Technical
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...