Cover: As I assume the role of the 2025–2026 ISPE International Board of Directors Chair, I reflect on GAMP® not as a static set of practices, but as an evolving framework that has enabled our industry to embrace digitalization and innovation while also preserving the trust regulators and patients place in pharmaceutical manufacturing.
Feature: The journey of an ISPE Emerging Leader is one defi ned less by titles and more by growth, resilience, and the willingness to learn. Over the past several years, I’ve come to recognize a set of lessons that continue to guide my own path and the paths of many peers in the ISPE Emerging Leader community.
Feature: The new manager of the company’s leading biotech facility was facing her toughest challenge yet. Known for her sharp leadership and technical skill, she’d handled complex operations before—but this situation pushed her to the edge, demanding quick decisions, crossteam coordination, and unwavering resilience.
Feature: Computerized system validation (CSV) remains a cornerstone of regulatory compliance, but it is still time-consuming, resource-intensive, and prone to human error. Risk assessments, test development, traceability, and documentation absorb enormous effort and often slow down innovation. Artificial intelligence (AI) has the potential to change this.
Categorization offers a useful starting point for assessing the risk of failure for individual software components, but it is not a validation checklist. Organizations must apply critical thinking to combine categorization with risk assessment and supplier assessments to appropriately scale life cycle activities and manage risk.
This article presents a model for promoting data quality of real-world data and evidence (RWD/RWE) and GxP processes with references to ISO 8000 for data quality management, making it a common language between regulated and nonregulated organizations.
Data integrity drives quality and compliance. Content addressable storage (CAS) stores and retrieves files by content type—not file location—using cryptographic fingerprints. The result: a mathematically provable version control, without broken links and far fewer audit headaches.
A single global digital chemistry, manufacturing, and controls (CMC) dossier is rapidly transitioning from a bold vision to a practical reality. However, realizing the full potential of these innovations requires significant coordination to harmonize and align across initiatives.
The journey of an ISPE Emerging Leader is one defined less by titles and more by growth, resilience, and the willingness to learn. Over the past several years, I’ve come to recognize a set of lessons that continue to guide my own path and the paths of many peers in the ISPE Emerging Leader community.
To accelerate the adoption of innovation in the global administration of the pharmaceutical industry, regulatory authorities and industry trade organizations must expand their scope and pursue a collaborative approach to recognition and reliance to streamline processes, enhance product quality, and improve patient access to medicines.
The 2026 ISPE Facilities of the Future (FOF) Conference will be held 2–3 February in San Diego, California, United States, and virtually. Lindsey Daniel, the conference’s Executive Chair, offers advice and shares what attendees can expect at the upcoming conference.
2025 was a remarkable year—one defined by resilience, growth, and meaningful celebration. Although the industry faced its share of challenges, our membership remained strong and steadfast.
Pharmaceutical Engineering® is proud to announce that the 2024 Roger F. Sherwood Article of the Year is “3R Initiative Within Roche’s Global QC Network” (November/December 2024) by Sven M. Deutschmann, PhD.
The 2025 ISPE D/A/CH workshop on “Pharma’s Journey to Digital Manufacturing and Supply” united pharma leaders, technology experts, and regulatory authorities for three days of intense exchange on the digital transformation of our industry.
Thanabalan “Thana” Subramanian is Head of the Digital Quality team in the quality, regulatory, digital consultancy firm Product Life Group. He is responsible for a team of 20 consultants and supports the Digital Quality Center of Excellence, covering IT compliance, computer software validation (CSV), data integrity, CSV auditing, and CSV training. Before joining Integrity, he worked for...
Frank Henrichmann is an expert in quality management, computerized system validation, and compliance, especially in clinical trials and pharmacovigilance. With over 25 years of experience in quality functions within the pharmaceutical industry, he has gained deep expertise in implementing and validating computerized systems within GxP-regulated environments, having worked with organizations...
As I assume the role of the 2025–2026 ISPE International Board of Directors Chair, I reflect on GAMP® not as a static set of practices, but as an evolving framework that has enabled our industry to embrace digitalization and innovation while also preserving the trust regulators and patients place in pharmaceutical manufacturing.
ISPE names CSL Behring the 2025 ISPE Facility of the Year Awards (FOYA) Overall Winner for its Project Aurora Plasma Base Fractionation Facility (Facility F). CSL Behring was honored with this prestigious award recognizing innovation and excellence in pharmaceutical facility projects, as the FOYA program celebrated its 20th anniversary.
The ISPE International Honor Awards provide the opportunity for all of us to recognize and celebrate the dedicated professionals volunteering countless hours to support ISPE in its mission.
ISPE elected a new 2025–2026 International Board of Directors, which is responsible for the governance and strategic direction of ISPE.
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Gabriela Kantor, Technical Editor, Publications team.
The newly published ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms encourages broader adoption of continuous manufacturing (CM).
Advanced therapy medicinal products (ATMPs) represent a revolutionary frontier in medicine, offering life-changing treatments for conditions previously deemed incurable. However, the intricate nature of these therapies, from their unique raw materials to complex manufacturing and logistics, presents significant challenges and inherent risks, including how to best develop validation methods and...
