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.
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.
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.”
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.
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.
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.
The landscape of clinical trials has been transformed in a post-pandemic world. In July, ISPE released the second edition of ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice. It addresses managing complexities associated with decentralized clinical trials, the benefits and challenges of using open-source software, and...
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.
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.
Mike Martin assumed his new role as President and CEO of ISPE and the ISPE Foundation in January.
The new ISPE International Board of Directors was introduced, the gavel was passed to a new Chair, and Honor Award Winners were announced on 15 October 2024 during the 2024 ISPE Membership Meeting and Awards Lunch in Orlando, US, during the 2024 ISPE Annual Meeting & Expo.
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.
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...
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...
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,...
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.”
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.
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.
The intersection of 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. AI in the life sciences seeks to unravel intricate biological phenomena through systematic assimilation, analysis, and interpretation of expansive and diverse datasets.
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.
Technology is advancing at an extraordinary rate. Industries are benefiting from automation and AI. As technological developments continue to reform the way industries run, the integration of AI and machine learning technologies in the life sciences industry is redefining the traditional approach to commissioning, qualification, and validation (CQV) in pharmaceutical manufacturing.
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.
Risk assessment is essential, however, risk assessment is of limited value if it is not conducted by a team with the necessary process, product, and functional understanding. Conducting risk assessments prematurely may lead to invalid assessment of overall risks. Conducting risk assessments too late will limit the opportunity to address design flaws and effectively test processes and...
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.
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.
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.
The 2025 ISPE Facilities of the Future (FoF) Conference will be held 27–28 January in San Francisco, California, US, and virtually. Mike Martin, the conference’s Executive Chair, offers advice and shares what attendees can expect at the upcoming conference.
The 2025 ISPE Aseptic Conference will be held 17–18 March in Washington, DC, and virtually. Christa Myers, the Conference Chair, offers advice and shares what attendees can expect at the upcoming event.
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.
