Cover: Technological innovations like process intensification, continuous manufacturing, and 3D printing are enabling transportable and point-of-care (PoC) medicines manufacturing— especially for personalized therapies such as cell and gene therapies and ATMPs. These flexible systems offer supply chain advantages but face regulatory and scalability challenges.
Feature: To foster continuous improvement and address challenges streamlined and flexible approaches for managing analytical procedures are essential. This article presents ve future-state scenarios illustrating how ICH Q14 can simplify post-approval changes, enhance regulatory effciency, and improve product quality—ultimately benefiting patients.
Feature: The International Council for Harmonisation (ICH) Q2(R2) and Q14 guidelines, finalized in late 2023, outline strategies for analytical procedure development, validation, and lifecycle management. As global implementation progresses, ISPE’s PQLI® Analytical Method Strategy Team surveyed industry stakeholders in mid-2024 to assess readiness, identify opportunities, and highlight areas needing alignment between sponsors and regulators. Survey results indicate the new guidelines offer significant opportunities, though some challenges remain. Continued collaboration between sponsors and regulators is key to ensuring the guidelines have the greatest impact for improved and streamlined implementation and maintenance of analytical procedures.
Feature: In April 2023, ISPE launched a survey to understand the sources of barriers to technological innovation within the pharmaceutical industry. This survey is part of an expansive and significant initiative by ISPE, Enabling Global Pharma Innovation: Delivering for Patients, which aims to promote consistent and harmonized interpretation and implementation of guidelines issued by the International Council for Harmonisation (ICH). The overarching goal is to improve global patient access to innovative medicines and technologies.
Feature: Defining requirements for calibration and routine testing of weighing equipment in the laboratory and production remains a complex endeavor for pharmaceutical companies. Applying sound, risk-based metrological strategies across the entire pharmaceutical value chain will help manufacturers ensure compliance, consumer safety, and commercial success.
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Amanda Banninga, Program Manager, Conferences & Digital Engagements.
ISPE successfully assisted Health Canada with International Council for Harmonisation (ICH) Q13 implementation training in virtual sessions with 170 participants.
As professionals in pharmaceutical engineering, we are challenged to develop medications and therapies more quickly and less expensively than ever before while maintaining safety and efficacy. It can be hard to know where to turn when you have an issue you cannot resolve or difficult to find your next bit of inspiration. The ISPE Annual Meeting & Expo is a great opportunity for us to come...
Advancements in technology—such as process intensification, continuous manufacturing, and 3D printing—are enabling transportable and point-of-care (PoC) medicines manufacturing, especially with the rise of personalized medicine. Modular, small-scale production systems are particularly well-suited for cell and gene therapies and other advanced therapy medicinal products (ATMPs) designed for...
In April 2023, ISPE launched a survey to understand the sources of barriers to technological innovation within the pharmaceutical industry. This survey is part of an expansive and significant initiative by ISPE, Enabling Global Pharma Innovation: Delivering for Patients, which aims to promote consistent and harmonized interpretation and implementation of guidelines issued by the International...
The United States Pharmacopeia (USP) Packaging and Distribution Expert Committee approved chapters 665 and 1665 in 2024. These chapters establish clear and general guidelines for the use of plastic materials in process equipment used within the pharmaceutical and biotechnology industries. Their publication has raised new questions regarding the role of polymeric materials in manufacturing...
Defining requirements for calibration and routine testing of weighing equipment in the laboratory and production remains a complex endeavor for pharmaceutical companies. Applying sound, risk-based metrological strategies across the entire pharmaceutical value chain will help manufacturers ensure compliance, consumer safety, and commercial success.
The International Council for Harmonisation (ICH) Q2(R2) and Q14 guidelines, finalized in late 2023, outline strategies for analytical procedure development, validation, and lifecycle management. As global implementation progresses, ISPE’s PQLI® Analytical Method Strategy Team surveyed industry stakeholders in mid-2024 to assess readiness, identify opportunities, and highlight areas...
Simplified approaches that enable changes to analytical procedures over their lifecycle are needed to allow continual improvements and adaptations due to technological obsolescence and other challenges. This article reflects on the positive impact that the recent ICH Q14 guidance can have on facilitating these changes. Five examples are provided that are based on scenarios in which analytical...
ISPE is proud to celebrate its 45th anniversary of working with regulators and professionals from across the industry and around the world to shape the future of pharma. This year also marks the 20th anniversary of the ISPE Facility of the Year Awards (FOYA), which celebrates extraordinary achievements in pharmaceutical manufacturing.
The new ISPE GAMP® Guide: Artificial Intelligence provides a comprehensive, state-of-the-art best practice framework to efficiently and effectively achieve high-quality AI-enabled...
The pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace, while lowering drug costs, enhancing quality, and maintaining safety and a robust supply chain.
When I began my journey in the pharmaceutical industry over 25 years ago, the environment was markedly different from what we see today. We operated in a world dominated by paper-based systems, outdated training videos from the 1980s, and a heavy reliance on self-directed reading. Career progression was more about navigating an informal ladder—gaining experience, demonstrating capability, and...
There is a dated leadership model known as the “Great Man” theory. It posits that history has been largely shaped by highly influential and exceptional individuals who, through natural attributes such as superior intellect, heroic courage, and outstanding leadership skills, have had a decisive impact on historical events.
“Excellence, then, is not an act, but a habit,” wrote the historian and philosopher Will Durant. However, when considering habits of excellence, or quality, we ought to first consider the origin of these habits. These habits originate from our thought patterns and are the architects of our actions. This means that quality actions begin with quality thoughts.
As fall approaches, it brings with it one of the most anticipated events in our industry: the 2025 ISPE Annual Meeting & Expo. More than just a conference, it’s a dynamic gathering where pharmaceutical professionals from around the world come together to exchange ideas, explore innovations, and strengthen our global community.
Celeste Frankenfeld Lamm encourages young professionals to identify and pursue the aspects of their jobs they feel passionate about, “The things that get you out of the bed in the morning tend to be the areas where you are going to perform strongly. Once you’ve identified them, it’s important to make your own opportunities. Let leadership know your work passions, express interest in teams or...
Nina S. Cauchon is Director Regulatory Affairs (RA) Chemistry, Manufacturing, and Controls (CMC) at Amgen Inc. where she leads RA-CMC advocacy and external engagement. She has experience leading both early phase and commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies, CMC aspects of...
As regulatory trends and quality initiatives continue to evolve in the pharmaceutical industry, this issue examines industry rules that support continuous improvement across the product lifecycle.
