For companies focused on producing lifesaving treatments, the positive effects of employee health, well-being, and satisfaction can be easily overlooked, but those positive effects are real. An investment in people results in better research, testing, and manufacturing processes, which leads to more efficient delivery of therapies and treatment to patients worldwide.
Organizations must continually evolve and adapt in order to grow, sustain, and stay competitive. No organization survives for a long period of time if it does not change with the times. The pace of change is accelerating, and the scale of disruptive market forces is growing by the day.
Trish Melton, PhD, has over 30 years of experience in the pharmaceutical industry, working in both manufacturing and service organizations. She is the Founder and Managing Director of MIME Solutions Ltd., a consultancy that has been providing support to the global pharmaceutical industry for 21 years in areas such as project, quality, and risk management, as well as in developing...
Ferdinando E. Aspesi, PhD, is a Senior Partner at Bridge Associates International, LLC, New Jersey, USA, where he advises pharmaceutical companies on quality strategy, organizational design, and quality and compliance issues. In his more than 44 years of experience in the industry, Aspesi has worked in active pharmaceutical ingredient (API) and drug products quality assurance and quality...
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.
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....
In the pharmaceutical industry, disaster recovery is not just about protecting business continuity; it is about safeguarding patient safety, data integrity, and the entire supply chain. The increasing complexity of global pharmaceutical operations exposes companies to a broad spectrum of risks, ranging from man-made disasters such as geopolitical conflicts to natural disasters that can cripple...
ISPE’s Q12 Implementation team, a working group under the auspices of ISPE's Product Quality Lifecycle Implementation (PQLI)® committee, continued their series of training events with a well-attended course delivered to Singapore’s Health Sciences Authority (HSA) in November 2024.
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its series of blog posts, where committee members and other contributing subject matter experts dive into the validation and use of essential equipment and processes that drive sterile processing in the pharmaceutical industry. The aim is to provide practical insights that will enhance your...
Per- and polyfluoroalkyl substances (PFAS) have emerged as a major concern in the pharmaceutical industry and beyond. Restricting their use is heavily debated. On the one hand, these “forever chemicals” can pose environmental and human health risks. On the other hand, their unique physical and chemical properties can make them important for pharma and ultimately for helping to enable access to...
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 2024 ISPE Pharma 4.0™ and Annex 1 Conference in Rome, Italy in December 2024.
In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory landscapes, and emerging global challenges such as supply chain disruptions, and drug shortages have significantly impacted how we develop, manufacture, and deliver treatments. These factors underscore the critical need for robust validation approaches for computerized systems to safeguard patient...
The US pharmaceutical manufacturing sector is preparing for continued, significant growth over the next decade, fueled by robust investments and evolving market demands. At the same time, this growth presents significant challenges—chief among them, the imperative to attract and retain a highly skilled workforce and to integrate advanced technologies that streamline operations and boost...
In the pharmaceutical industry, expertise is essential—but connection is what turns expertise into impact. No single professional, company, or discipline holds all the answers to the challenges we face. Progress happens when experts come together, share knowledge, and build upon one another’s insights. That’s exactly what ISPE enables: a global network of professionals who not only advance...
The pharmaceutical industry is undergoing a significant transformation, moving away from traditional paper-based validation processes to adopt digital validation tools (DVTs). This transition began with electronic validation repositories, enabling the digital creation, uploading, and electronic approval of documentation—securely stored and meeting electronic records and signatures compliance...
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 2024 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...
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...
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Isabella Stoup, the ISPE Foundation, Senior Coordinator, Development.
Crafting and communicating a vision for the organization is one of the most important and visible jobs of a leader. It is also a difficult job, and executing plans to realize the vision is even more difficult.
The expectations for the workforce joining the industry right now are slightly daunting. It can feel like being required to be everything at once: flexible but driven by purpose, extremely adaptable but stable at the core, empathetic but independent, and knowledgeable but versatile.
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Integrating Environmental Monitoring System (EMS) data into your Quality Management System (QMS) isn't just about compliance—it’s about building a robust foundation for risk management, process optimization, and product integrity.
The aim of this article is to help understand the main containment principles and to present the steps to be followed when establishing a containment strategy. It provides an overview of the “ISPE Good Practice Guide: Containment for Potent Compounds”, published in December 2022. The guide is a success of knowledge consolidation to create a...
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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