These sessions offer attendees a unique opportunity to engage directly with the authors, contributors, and experts behind newly released and forthcoming ISPE Guidance Documents—each addressing critical aspects of digital transformation, advanced manufacturing, risk management, RNA-based therapeutics, and modernized commissioning and qualification.
Whether a technical leader, quality professional, digital transformation champion, or operations specialist, the Spotlight Sessions promise valuable insights into where the industry is headed and how organizations can prepare.
A Guided Tour of What's New: Five Featured ISPE Publications
1. ISPE Pharma 4.0™ Good Practice Guide: Holistic Digital Enablement (First Edition)
Published November 2025
Pharma’s digital evolution continues to accelerate, and with it, the need for robust, flexible frameworks that help organizations navigate the complexity of digital transformation. The ISPE Pharma 4.0™ Good Practice Guide: Holistic Digital Enablement fills this need by highlighting how emerging technologies—AI, machine learning, internet of things, process analytical technologies, blockchain, and big data analytics—are reshaping the pharmaceutical value chain.
But the Guide goes beyond technology. It emphasizes that Pharma 4.0™ is a holistic cultural and organizational transformation, one that must address:
- Evolving regulatory expectations
- Persistent data governance gaps
- Workforce upskilling needs
- Legacy technology constraints
- Cybersecurity and integration hurdles
- Fragmented data standards and formats
Importantly, the Guide is role-agnostic and relevant across the entire organization—from quality, operations, and research and development to information technology/operational technology (IT/OT), supply chain, human resources, and commercial functions.
Its flexible, maturity-based approach equips companies to tailor best practices to their digital readiness, enabling smarter, more connected operations and improved patient outcomes.
2. ISPE GAMP® Good Practice Guide: GxP Process Control Systems (Third Edition)
Published March 2026
This major update to a foundational GAMP resource reflects the evolution of manufacturing systems and automation technologies. Fully aligned with ISPE’s latest guidance—the ISPE GAMP® 5 Guide (Second Edition), the ISPE GAMP RDI Guide on Data Integrity for Manufacturing Records, and the ISPE GAMP Guide to Enabling Innovation—the new edition delivers clarity and direction for designing, implementing, and maintaining compliant, effective process control systems (PCSs).
Key areas of advancement include:
- Modular and adaptive plant design
- Cloud hosting and SaaS-enabled control system components
- Modern software development tools
- AI-supported automation
- OT cybersecurity
- Expanded application to continuous manufacturing, personalized medicine, and medical device production
Notably, the Guide strengthens alignment between PCSs and equipment lifecycle activities defined in the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition). This integrated view helps companies improve data integrity, streamline implementation, and reduce compliance risk—while accelerating digital innovation.
3. ISPE Guide: Quality Risk Management Best Practice (First Edition)
To be published in 2026
The forthcoming Quality Risk Management (QRM) Best Practice Guide delivers a comprehensive and practical interpretation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9(R1), aimed at addressing persistent challenges in QRM implementation such as:
- Over formality
- Excessive subjectivity
- Misalignment between risk decisions and product availability
- Erosion of risk-based decision making
The Guide expands beyond the ICH framework by integrating additional standards, regulations, and ISPE resources that connect revision themes to real-world application. Readers can expect:
- Detailed examples and case studies
- Clear methods for establishing effective QRM programs
- Tools that strengthen decision-making consistency
- Emphasis on continuous, cyclical risk management—not one time assessments
By reinforcing the foundational elements of QRM, this Guide aims to help companies embed risk-based thinking throughout development, manufacturing, and distribution.
4. ISPE Guide: RNA-Based Therapeutics Manufacturing (First Edition)
To be published in 2026
RNA therapeutics continue to redefine the boundaries of biomedicine, and with their rise comes the need for new manufacturing paradigms. Unlike traditional biologics, RNA-based products are not tightly defined by their production processes, enabling more flexible and scalable facility design.
This Guide provides foundational principles—not prescriptive requirements—to support facilities customized to the risks and process needs specific to RNA:
- Reduced reliance on rigid cleanroom classifications
- More adaptable layouts compared to conventional biologics plants
- Consideration of decentralized and point-of-use production
- Risk-based minimum requirements to avoid overspecification
Reflecting rapid RNA innovation, illustrated by the unprecedented development speed of COVID 19 vaccines, the Guide champions future-ready architectures that enable modernization and scalability.
5. ISPE Baseline® Guide, Volume 5: Commissioning and Qualification (Second Edition) – 2026 Addendum
To be published in 2026
Built on recent industry survey data (2023–2024), the 2026 Addendum addresses gaps and inconsistencies in applying QRM to commissioning and qualification (C&Q). It provides enhanced guidance on:
- Defining and harmonizing critical quality attributes, critical process parameters, critical attributes, and critical data elements
- Applying quality risk management (QRM) principles to Established Conditions (ICH Q12)
- Aligning C&Q risk assessments with ICH Q9(R1) and control strategy concepts
- Introducing PCS qualification
The Addendum reinforces a clear message: failure to embed risk-based C&Q increases regulatory and product risk. When properly implemented, QRM-based C&Q:
- Enhances product quality and patient safety
- Reduces regulatory exposure
- Accelerates project delivery
- Supports modernized manufacturing approaches
It also provides an updated overview of the C&Q delivery process, ensuring alignment with contemporary industry expectations.
Join the Spotlight Sessions in Copenhagen
With their strategic timing during lunch and networking breaks, the Spotlight Sessions offer a convenient way to gather insights, ask questions, and connect with leaders driving some of ISPE’s most impactful guidance work.
Whether preparing for digital transformation, advancing your risk-management program, designing next-gen facilities, or adapting to new regulatory expectations, these sessions provide guidance to bring back to teams—and put into practice.
Learn more and register
