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.
ISPE GAMP® 5: A Risk Based Approach to Compliant GxP Computerized Systems (Second Edition),1
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.
Technology is advancing at an extraordinary rate. Industries are gaining the benefits of automation and artificial intelligence (AI). The life sciences industry is no exception.1
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.
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...
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.
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...
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.
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.
Mike Martin assumed his new role as President and CEO of ISPE and the ISPE Foundation in January.
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.
This article describes the numerous activities in the commercial quality control (QC) network that aim to replace in vivo assays with alternative methods in the course of production and release.1
Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This article introduces some of the key points, actual methods, and practical examples of our implementation to reduce carbon emissions from pharmaceutical manufacturing facilities in Southeast Asia.
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...
The pharmaceutical industry faces considerable challenges throughout the development, manufacturing, and supply of medicines, largely due to the intricate and divergent global regulatory landscape. The adoption of structured data standards and utilization of cloud-based platforms offer immense potential to overcome these challenges by facilitating faster and more efficient global...
On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to representatives from the Austrian Agency for Health and Food Safety (AGES), US Food and Drug Administration (FDA), Regierungspraesidium Tübingen (RP Tübingen), World Health Organization (WHO), Therapeutic Goods Administration (TGA), and...
The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies provide new opportunities to boost productivity through continuous process improvements. The Pharma 4.0™ framework, an adaptation of the broader Industry 4.0 movement, aims to transform how drugs are produced and delivered.
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies is accelerating, introducing tough decisions for manufacturing development. Gene editing therapy production is complex, often involving multi-modality manufacturing operations in one facility to produce a single therapeutic. This article considers whether retrofitting an aging monoclonal...
Implementing advanced automation technologies is a strategic move that can amplify the positive outcomes of environmental, social, and governance (ESG) initiatives. By leveraging ESG initiatives, pharmaceutical companies can enhance their competitive edge and contribute positively to global sustainability efforts.
Cell and gene therapy (C>) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...
The US Food and Drug Administration (FDA) advocates for the integration of quality by design (QbD) principles throughout the pharmaceutical product development landscape, aiming to elevate both process understanding and product quality. Key challenges to the process control strategy include navigating time- and resource-intensive processes. One solution is digital shadow technology which, when...
In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and ensuring quality is a critical success factor. An effective quality risk management (QRM) system is a key component in the overall quality management infrastructure of biopharmaceutical organizations. It offers a structured, scientific, and risk-based approach to decision-making, addressing potential...
Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C>s) represent a promising medical product class that employs gene therapy, cell therapy, or tissue engineering to address various diseases and injuries. One critical aspect of ATMP and C> manufacturing is using cell culture media. With thousands of ATMPs and C>s in clinical trial phases, the role of...
A set of principles to be considered in the journey to adopting and deploying an architecture capable of supporting Pharma 4.0 Plug & Produce capability.
Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers worldwide are urged to increase production efficiency by making better use of time and resources. This is in addition to addressing the unique challenges faced by pharmaceutical manufacturers such as a strictly regulated environment, heterogeneous equipment suppliers, and long adaptation times....
This Concept Paper proves that a standard model within OPC UA Alarms and Conditions (OPC UA Part 9) can be leveraged to realize Plug & Produce for exchanging pharmaceutical alarms and audit trails between OT manufacturing equipment and Orchestration Platforms or IT Services like EBR or Historian.
As the pharmaceutical industry continues to evolve at an unprecedented rate, the design and delivery of manufacturing facilities must keep pace with the associated changing requirements. The drivers for change are also diverse both with internal and external factors being relevant. For facility design this means a more focused risk-based approach is followed. The result is facilities which...
In the fast-paced and ever-evolving world of pharmaceutical manufacturing, companies must respond to and navigate complex challenges to minimize risks and assure their manufacturing strategies deliver measurable value. As businesses evaluate whether to modify, expand or design new facilities, they must define and develop a robust and resilient framework for their manufacturing spaces and...
The 2024 ISPE International Honor Awards, presented at the 2024 ISPE Annual Meeting & Expo, enable the ISPE community to recognize and celebrate ISPE members who go above and beyond in supporting ISPE and its...
Expanding on the traditional focus of ISPE’s Facility of the Year Awards (FOYA), United Therapeutics has earned an Honorable Mention in the Social Impact category for their extraordinary...
In 2024, the Facility of the Year Awards (FOYA) honored Zydus Pharmaceuticals with an Honorable Mention for their state-of-the-art Oral Solid Dosage (OSD) manufacturing facility in Ahmedabad, Gujarat, India. This recognition highlights Zydus’s commitment to innovation, efficiency, and patient accessibility within the pharmaceutical industry.
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.
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.
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.
The article “Comparability Considerations for Cellular and Gene Therapy Products,” published in the November/December 2023 issue of Pharmaceutical Engineering, has been named...
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.
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.
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.”
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.
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.
ISPE has announced the new 2024-2025 ISPE Affiliate and Chapter Council Chairs and Co-Chairs. ISPE Regional Affiliate Councils collaborate efficiently with the international ISPE organization and local regional peers to ensure optimal alignment and support for local success. ISPE currently has three regional affiliate councils including: Asia-Pacific Affiliate Council (APAC), European...
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of Asset Management programs at each company. The initial sessions were a success, covering topics such as Asset Condition Evaluations and Asset Management Governance. CSL was keen to continue the conversations and gather more insights on certain...
At the 2024 ISPE Annual Meeting & Expo, in Orlando, Florida, this past October, ISPE proudly recognized Niranjan Kulkarni, PhD, with the prestigious Max Seales Yonker Award, as part of the 2024 International Honor Awards. Kulkarni was honored for his extraordinary volunteer service, leadership, and unwavering commitment to...
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues, or cells. This class of products cannot be terminally sterilized and, in many cases, cannot be filtered and are manufactured by Aseptic processing. The increase in demand for these life-changing products has been fraught with technical and regulatory challenges as laboratory processes are scaled to commercial...
ISPE’s Pharma 4.0™ Baseline Guide authoring team received the prestigious Committee of the Year Award, as part of the 2024 ISPE International Honor Awards which were presented at this year’s 2024 ISPE Annual Meeting & Expo., The Committee of the Year Award recognized the Pharma 4.0™ Baseline Guide Authoring Team for their...
The pharmaceutical industry is undergoing a remarkable transformation, with advanced modalities like antibody-drug conjugates (ADCs) and radiopharmaceuticals driving the evolution of precision medicine. These innovations are not only redefining drug development but are also improving patient outcomes through targeted therapies, reduced side effects, and expanded treatment options. The...
On 16 October at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, USA, Emer Cooke, European Medicines Agency (EMA) Executive Director and chair of the International Coalition of Medicines...
In this blog post, Charlie Wakeham, Director of WakeUp to Quality and Chair of the ISPE GAMP® Global Steering Committee, shares a recap of the ISPE Australasia Digital Innovation Conference, which took place 24 – 25 September 2024.
All economic sectors, including life sciences, are undergoing a significant transformation driven by the increasing focus on integrating environmental, social, and governance (ESG) criteria into their strategies and activities. This shift is crucial as companies face growing pressures from stakeholders such as customers, regulators, suppliers, and employees to act responsibly and...
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Authored by Digital Validation expert Darragh Boyle, this Kneat eBook reveals the power of digitalization to transform your equipment validation processes — enabling you to enhance operational efficiency and regulatory compliance, reduce costs, and gain a competitive edge.
Walk-on ceilings are one of the more complex architectural features in controlled environments, requiring careful design and robust construction. GCS, a leader in cleanroom panels, explores the challenges, design considerations, and essential features of world-class walk-on ceilings for cleanrooms.
By implementing CSA, teams can accelerate software validation, reduce validation cycle times, and enhance compliance while freeing up valuable resources. Whether you are starting your CSA journey or refining existing processes, this Kneat guide — authored by CSV expert Darren Geaney — provides a clear and structured roadmap to success in 2025.
Whether networking at events or collaborating through our Communities of Practice, the value of an ISPE membership is in the connections made between pharmaceutical industry professionals and Regulators to collaborate on solutions to common goals and challenges.
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