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.
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 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 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.
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 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.
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...
Currently, there is no single guidance document providing a comprehensive roadmap for executing digital validation. While elements from ISPE GAMP® Guides Series and the ISPE Baseline® Guide: Volume 8 – Pharma 4.0™, apply to digital validation, there is no consolidated resource addressing common questions. The authors of this Concept Paper therefore advocate for the development of a Good...
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....
The future of the pharmaceutical industry is being shaped by rapid advancements in digital technologies, automation, and data analytics. As we look ahead to 2025, the concept of Pharma 4.0™ is no longer just an aspirational vision—it is becoming a transformative reality that will redefine how medicines are developed, manufactured, and delivered to patients.
Lindsey Daniel, Director of Product Operations Strategy and Business Lead at Takeda, is an exemplary champion for and beneficiary of ISPE. Daniel embodies leadership and collaboration in numerous ways: as a mentor, mentee, friend, colleague, mother, and more. With over 12 years of active involvement with ISPE, she has served on various committees, including ISPE’s International Women in...
In the pharmaceutical industry, ensuring the safety, quality, and efficacy of products is paramount. With the increasing complexity of manufacturing processes, the growing reliance on computerized systems and advancements in technology, GAMP® guidance provides a framework for validating and maintaining the integrity of computerized systems, ensuring they are fit for their intended...
The presentation by Ian Deveau, PhD, from the US Food and Drug Administration (US FDA) Office of Compounding Quality and Compliance at the ISPE Annual Meeting & Expo on 15 October 2024 provided an in-depth look at the US FDA’s perspective on drug compounding, its regulatory framework, and the significant events that have shaped current practices. Here is a summary of the key points covered...
Every dose of medicine represents a promise of quality—a commitment to safety, efficacy, and availability for the patients who depend on it. At the 2024 ISPE Annual Meeting & Expo, Jennifer Maguire, PhD, Director of the US Food and Drug Administration’s (US FDA) Office of Quality Surveillance (OQS), outlined how the agency is transforming its approach to pharmaceutical quality surveillance...
At the 2024 ISPE Annual Meeting & Expo, a session focused on lifecycle management considerations for cell and gene therapy was held. This session invited experts in their field to review...
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety (AGES) provided a much-anticipated presentation on the requirements for data management in light of the revised Annex 1 at the ISPE Pharma 4.0™ and Annex 1 Conference in Rome, Italy in December 2024.
Imagine your favorite sports team. Maybe it’s a football club with a rich history, a devoted fan base, and an energy that electrifies the stadium. Some people are casual viewers—they check the scores, maybe attend a game now and then. Others are fanatics (sometimes even crazed fanatics). They wear the jersey, know the stats, engage in every play, cheer and yell at the team and opponents, and...
The biotech sector, which includes advanced therapy medicinal products (ATMPs) including large molecules and cell and gene therapies, has been the fastest growing market in the pharmaceutical industry for years and this is not expected to change in the next few decades. In addition to products already on the market and new products in development, the market will additionally grow in...
As we approach International Women’s Day 2025, this year’s theme highlights the importance of accelerating action. ISPE’s Women in Pharma® embodies these principles by creating a platform for connection, growth, and empowerment. Hear what these Women in Pharma® members have to say about the value of Women in Pharma on International Women’s Day.
The pharmaceutical industry is one of the most dynamic and regulated fields globally, where staying ahead of the curve is not just beneficial—it's essential. Professionals need reliable, up-to-date resources to navigate the complexities of regulatory requirements, technological advancements, and industry best practices. This is where the International Society for Pharmaceutical Engineering...
As aseptic processing evolves rapidly both from technological and regulatory perspectives, the 2025 ISPE Aseptic Conference will feature a full
The 2025 ISPE Europe Annual Conference will take place from Monday, 12 May to Wednesday, 14 May 2025 in London, United Kingdom. Participants will be able to attend in person or virtually. Heather Watson,...
What does it mean to be a “team member?” What ideas come to mind in your favorite sport where you think of membership on that team or club?
What happens when you change the perspective to “team player?” What ideas come to mind then? Will the group have improved performance when it is full of team players rather than just team members?
Chris Leman received the ISPE United Kingdom (UK) Affiliate Member of the Year Award at the ISPE UK Affiliate Annual Conference and Awards Dinner in London, Heathrow in November 2024. Leman was honored as ISPE UK 2024 Member of the Year in recognition of his incredible contributions which included leading the ISPE UK North West region, creating the new UK Commissioning and Qualification...
The pharmaceutical industry continues to face increasing demands for more efficient and effective manufacturing processes, particularly when it comes to aseptic processing. With an emphasis on safety, sterility, and the quality of biologics and injectables, the field of aseptic processing is critical for delivering life-saving medications. ISPE invites all pharmaceutical professionals to join...
In this blog post, ISPE Emerging Leader member Peyton Myers, details his experience in his first year as an ISPE member. Myers was attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient and earned a two-year membership with the organization as part of the
Advances in pharmaceutical regulation and pharmaceutical technology don’t always coincide. Each advancement moves on its own schedule, driven by its own unique forces. But sometimes there is a synergy, when advances in technology can help regulators to achieve their objectives and changes in regulation come at just the right time to enable a technology to be impactful. This interplay between...
In the “Technology, Digital Transformation, and Pharma 4.0™” track at the upcoming 2025 ISPE Facilities of the Future Conference, audiences will have the opportunity to learn how cross-industry...
The 2024 ISPE International Honor Awards enable the ISPE community to recognize and celebrate the dedicated professionals who volunteer countless hours to support ISPE and its mission. This year’s awards were presented in October at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, USA.
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...
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