January / February 2025

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Updated GAMP® GPG Incorporates AI and Open-Source Software

Cover: The landscape of clinical trials has been transformed in a post-pandemic world. The first edition of the ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice was issued in 2017. In July 2024, ISPE released the second edition [1] which addresses managing the complexities associated with an uptick in decentralized clinical trials, the benefits and challenges of using open-source software, the use of data science and AI in clinical trials, data privacy, and data processing.

A GAMP® Approach to Computerized System Life Cycle and IT Process Records

Feature:  This article describes a practical and pragmatic approach to the management of computerized system life cycle and information technology (IT) process records. The objective is to effectively achieve and maintain compliant GxP-regulated systems that are fit for intended use, and to support patient safety, product quality, and data integrity.

Removing the Frustration from Functional Risk Management

Feature:  ISPE GAMP® 5: A Risk Based Approach to Compliant GxP Computerized Systems (Second Edition), section 2.1.4 states “Quality Risk Management (QRM) is a systematic process for the identification, assessment, control, communication, mitigation, and review of risks.”

Production Systems: The Role of AI and ML in Efficiency and Innovation

Technical: The integration of artificial intelligence (AI) and machine learning (ML) into bioprocess development represents a rapid shift in the way discovery, development, optimization, and production of biological products are approached.

Artificial Intelligence: Artificial Intelligence in Drug Target Discovery

Technical: The intersection of artificial intelligence (AI) and drug development has ushered in a transformative era, revolutionizing the way researchers approach biomarker/target identification, drug/target interactions, and drug-like molecule design. Rooted in an interdisciplinary fusion of computer science, statistics, and biology, AI in the life sciences seeks to unravel intricate biological phenomena through systematic assimilation, analysis, and interpretation of expansive and diverse datasets.

Packaging and Handling Processes: Reevaluating Transfer of RTU Containers into Grade A

Technical:  At first glance, ready-to-use (RTU) primary packaging material (tub systems) give production lines more flexibility and reduce container preparation complexity for aseptic fill/finish operations. However, the aseptic introduction of RTU tub systems requires a thoroughly designed transfer process to avoid contamination of the sterile RTU items and the aseptic core.

In This Issue

InTouch

It is a rare and wonderful legacy to have substantially improved your chosen industry and to have bestowed a name on an initiative that, 30 years later, has become synonymous with best practice. This article celebrates both these pivotal achievements of Anthony (Tony) Trill, who passed in 2024.

InTouch

Since its original publication in 2009, the ISPE Good Practice Guide: Heating, Ventilation and Air Conditioning has been helping engineers design heating, ventilation, and air conditioning (HVAC) systems that meet regulatory compliance while maintaining product safety, worker safety, and comfort.

Insights

For nearly half a century, ISPE has served as a resource for the industry. With a global footprint that includes 22,000 members representing 120 countries, we continue to provide guidance to address pressing challenges within the industry.

InTouch

Brandi Stockton is Founder of The Triality Group, LLC, where she provides quality, regulatory, and compliance consulting services for life sciences companies. She has more than 20 years of GxP experience, with a specialization in computer systems quality and data integrity. Brandi joined ISPE in 2014. In addition to being chair of the GAMP Americas Community of Practice, she is a member of the...

InTouch

Mark Cherry is the IT Compliance Director and GXP subject matter expert at AstraZeneca. A chartered engineer, he has been with AstraZeneca for 22 years and was previously with GlaxoSmithKline in a variety of computer compliance and engineering roles. He has been a member of ISPE since 1999.

In addition to serving on the GAMP Europe Community of Practice (CoP) as Chair, he led the team...

InTouch

In the ever-evolving landscape of the pharmaceutical industry, the Women in Pharma® Steering Committee has taken significant steps to foster collaboration, share insights, and strengthen community engagement among the ISPE community. Over the past year, our commitment to these initiatives has opened doors for Women in Pharma Affiliate and Chapter leaders to connect, exchange best practices,...

Insights

Mahatma Gandhi, Winston Churchill, and Golda Meir were some of history’s greatest leaders. One thing they all had in common was that they were leaders of incredible personal character. General Norman Schwarzkopf said, “Leadership is a potent combination of strategy and character. But if you must be without one, be without the strategy.”

Technical

At first glance, ready-to-use (RTU) primary packaging material (tub systems) give production lines more flexibility and reduce container preparation complexity for aseptic fill/finish operations. However, the aseptic introduction of RTU tub systems requires a thoroughly designed transfer process to avoid contamination of the sterile RTU items and the aseptic core.

Insights

For decades, success within the pharmaceutical sector was governed and constituted by linear career paths. A linear path, though predictable, may disregard an individual’s personal drivers and goals. Professional success should not only be defined through the height of your ladder position, but also by the alignment of your work to personal interests.

Technical

The intersection of artificial intelligence (AI) and drug development has ushered in a transformative era, revolutionizing the way researchers approach biomarker/target identification, drug/target interactions, and drug-like molecule design. Rooted in an interdisciplinary fusion of computer science, statistics, and biology, AI in the life sciences seeks to unravel intricate biological...

Features

This special anniversary article addresses the history and milestones that define the GAMP Community of Practice (CoP). In celebration of the 25th anniversary of the creation of GAMP Americas, we reflect on the vital role GAMP Americas has played in that journey. We commemorate key accomplishments of its members, share recent activities, and look ahead to the future of GAMP Americas.

Features

This article describes a practical and pragmatic approach to the management of computerized system life cycle and information technology (IT) process records. The objective is to effectively achieve and maintain compliant GxP-regulated systems that are fit for intended use, and to support patient safety, product quality, and data integrity.

InTouch

At the 2024 Facility of the Year Award (FOYA) Celebratory Banquet, ISPE announced the 2024 overall FOYA winner: Eli Lilly Kinsale Limited’s IE2b project. In addition to winning the overall award, Eli Lilly’s IE2b project was recognized as the 2024 Innovation category winner for its innovation in synthetic peptide manufacturing.

InTouch

Since our inception, the ISPE Foundation has continually invested in people and helped shape the future of the pharmaceutical industry. We continued this momentum last year and hope you will join us in supporting the workforce of the future in 2025.

InTouch

In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Laneisha Walker, Manager, Sales Operations.