Featured Articles

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Features
Closing The Loop: Closing Cell Therapy Manufacturing Processes

Cell and gene therapies (C&GTs) offer a groundbreaking approach for disease treatment by targeting conditions at the cellular and genetic level, offering hope for previously untreatable disorders. As these therapies progress from clinical trials to commercial reality, manufacturing challenges—particularly the need for robust, scalable, and cost-effective production—remain a significant...

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Features
Mold Risk in Cleanrooms: A Holistic Control Approach

Mold contamination is one of the most persistent threats to cleanroom integrity in pharmaceutical manufacturing. This article highlights the sources, growth conditions, and pathways for mold ingress. It emphasizes the need for an integrated approach combining facility design, environmental monitoring, effective investigation, and robust cleaning and sanitization programs.

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Technical
Fast-Tracking Drug Development: How Science, Strategy, and Structure Enabled Rapid CMC Success

This article presents experiences from seven recent accelerated development program case studies. These experiences provide insights that could help companies progressing through accelerated development programs for products meeting unmet medical needs or significant therapeutic needs, such as those with anticipated Breakthrough Therapy (United States) or PRIME (European Union) designation.

Artificial Intelligence and the Validated State
Technical
Artificial Intelligence and the Validated State

This article examines the regulatory landscape governing artificial intelligence (AI) in quality-critical systems and distinguishes between algorithms, AI, and a nuanced middle category called smart systems. It explains how organizations can responsibly embrace advanced programmatic solutions while preserving the integrity of validated test methods and safeguarding patient safety.

Lyophilizer Shelf Temperature Mapping: Part III: Data Analysis
Technical
Lyophilizer Shelf Temperature Mapping: Part III: Data Analysis

Shelf temperature mapping is a critical component of lyophilizer qualification. The previous articles in this series explored the methods used to record the shelf surface temperatures (Part I) and designing an appropriate study (Part II). Interpreting a shelf temperature mapping study’s result is as critical to assessing uniformity as the temperature measurement, the study design, and the...

Sustainability Challenges of Single-Use Technologies
Technical
Sustainability Challenges of Single-Use Technologies

The promise of single-use technologies (SUTs) in biopharmaceutical manufacturing is as compelling as it is contradictory. Noted for accelerating process development, enhancing sterility, and enabling unprecedented manufacturing agility, SUTs have also introduced a less visible but mounting challenge: the steady accumulation of complex plastic waste.

Co-Processed Excipients for Continuous Manufacturing of Drug Products
Technical
Co-Processed Excipients for Continuous Manufacturing of Drug Products

Bulk powders inherently exhibit unpredictable flow in feeders, dosing machines, and packed machines under gravity's pull. Meanwhile, particle engineering co-processed excipients can be more versatile and economical compared to conventional ingredients in the continuous manufacturing of drug products.

Digital Commissioning, Qualification, and Validation in Large Capital Projects
Features
Digital Commissioning, Qualification, and Validation in Large Capital Projects

In today’s pharmaceutical landscape, speed, compliance, and efficiency are no longer optional—they’re strategic imperatives. Yet for large capital expenditure (CapEx) projects, traditional paper-based commissioning, qualification, and validation (CQV) workflows remain a major bottleneck, consuming time, resources, and patience.

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Features
Driving the Future of Commissioning and Qualification: Inside ISPE’s New C&Q Implementation Addendum and Webinar Series
The pharmaceutical industry is at a pivotal moment. The pressure to deliver safe, high-quality medicines to patients faster has never been greater, and the systems used to ensure compliance must evolve to meet that challenge. Commissioning and qualification (C&Q), long the bedrock of pharmaceutical engineering and compliance are being reshaped by new science- and risk-based approaches that...
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Features
Unique Challenges of Radioligand Therapy Manufacturing

Radiopharmaceuticals account for many lifesaving diagnostic and therapeutic drug products in the market. These drug products, radioligand therapies (RLTs) in particular, represent a relatively novel modality and present multiple, unique challenges to manufacture, release, ship, and administer.

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Features
ASTM E2500-25 Standard Guide: Approval and Updates

ASTM E2500, issued in 2007, has been the primary standard guide defining what is required to apply quality risk management (QRM) to achieve the qualification of facilities, systems, and equipment in support of validation and process validation. A major update was undertaken in 2024 to better align the guide with current regulatory and industry guidance and current best practice.

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Features
Interdependency Matrix: Effective C&Q Project Management

Schedule management faces challenges such as unrealistic deadlines, scope creep, resource constraints, and poor communication, often causing delays and cost overruns. Using tools like an interdependency matrix (IDM) with project management software tools like Microsoft Project improves accuracy, visibility, and control.

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Features
Best Practices Preparing for a Commissioning and Qualification Audit

This article provides guidance on the best practices to adopt when preparing for an audit or inspection, with a particular focus on commissioning and qualification and the points to consider during the development of materials to explain a company’s individual approach to commissioning, qualification, and validation maintenance.

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Features
How AI Will Transform Computerized System Validation
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.
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Features
When Is a Category Not a Category?

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.

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Features
Seven Control Layers for LLMs in GMP Decision-Making
Large language models (LLMs) can enable decision support in pharmaceutical manufacturing but can also create risks through overreliance. LLM-enabled computerized systems have the potential to increase assessment consistency and performance in a scalable way for automated decision-making workflows.
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Features
Data Quality Management of Real-World Data and Evidence

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.

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Features
Content Addressability in the Future of Knowledge Management

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.

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Features
GAMP® and ICH GCP E6 Standards Keep Clinical Trials Current
Clinical trial sponsors who delegate responsibilities to service providers supporting anything from a small, single-site Phase I study to a global Phase III program are now operating under a fully revised ICH GCP E6(R3).
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Features
Expanding Extended Producer Responsibility: Challenges and Opportunities
Pharmaceuticals are not only regulated by traditional pharmaceutical legislation but are also increasingly influenced by related environmental and stewardship laws. Extended producer responsibility (EPR) is reshaping the pharmaceutical industry with regulatory burdens, challenges, and strategic opportunities.
Advancing Sustainability in C&Q Projects: From Inception to Eco‑Efficient Implementation
Features
Advancing Sustainability in C&Q Projects: From Inception to Eco‑Efficient Implementation

Sustainability principles can be effectively integrated into commissioning and qualification (C&Q) projects to support environmental goals without compromising compliance, quality, or patient safety. By positioning C&Q as both a verification tool and an enabler of sustainable intent, this article outlines a practical path for the pharmaceutical sector to enhance operational efficiency,...

Platform Drug Delivery Devices for Regulatory Submissions
Features
Platform Drug Delivery Devices for Regulatory Submissions

The development of platform drug delivery devices for combination products offers a transformative approach to drug delivery by enabling the reuse of device data across multiple drug and device combinations.

Industrial ATMP Manufacturing
Online Exclusives
Industrial ATMP Manufacturing: Digitization’s Role in Aseptic Manufacturing for ATMPs
Over the past decade, Advanced Therapy Medicinal Products (ATMPs) have introduced a significant shift to pharmaceutical manufacturing, introducing a new generation of personalized medicines that demonstrate promising results for diseases with few or no treatment options. In the United States, approximately 34,000 patients have received CAR T-cell therapies since 2024. With 17 authorized products...

Explore

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White Paper
Global Pharmaceutical Manufacturing Leadership Forum (GPMLF): Annex 1 White Paper
This whitepaper provides principles and practical expectations for manufacturing operations within the scope of GMP Annex 1, focusing on four areas: environmental monitoring and control; aseptic process validation; equipment and facility design; and personnel practices. Each subject area was drafted as an individual chapter to the whitepaper by multicompany and multidisciplinary teams with...
Technology and Innovation
White Paper
Digital Validation – Future Advances
The life science validation sector is evolving with a focus on risk-based methodologies and increased access to digital data, driving innovation. The rise of Digital Validation Tools (DVTs) reflects the industry's emphasis on data integrity and principles of Pharma 4.0 and Validation 4.0. These advancements streamline monitoring and provide real-time insights into validated statuses through...
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White Paper
Digital Validation – Use Cases, Challenges, Standards, and Regulatory Guidance

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...

Latest Articles

Inside ISPE’s Largest Affiliate: How D/A/CH Drives Engagement and Industry Progress
iSpeak Blog
Inside ISPE’s Largest Affiliate: How D/A/CH Drives Engagement and Industry Progress

The ISPE D/A/CH Affiliate, encompassing Germany, Austria, and Switzerland, represents a diverse and highly engaged community within one of Europe’s key pharmaceutical regions. The Affiliate was recognized as the largest of ISPE’s 40+ Affiliates and Chapters at the 2026 Facilities of the Future Conference in February, underscoring both the scale of the regional industry and the strength of its...

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iSpeak Blog
Meet Vivien Santillan, a 2026-2027 ISPE International Board of Directors Election Candidate

The 2026 ISPE International Board of Directors Election provides members with the opportunity to help shape the future of the Society by voting for representatives to fill open seats on the International Board. The Board plays a critical role in establishing ISPE’s vision and mission, setting strategic priorities, and ensuring that operations align with ISPE policies, best practices, and...

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iSpeak Blog
Where Innovation Becomes Delivery: Why the 2026 ISPE Annual Meeting & Expo Matters Now

The pharmaceutical industry has never lacked ambition. Across the globe, scientific discovery continues to move at extraordinary speed. New modalities, advanced therapies, precision approaches, digital platforms, automation, artificial intelligence, and novel manufacturing technologies are expanding what may be possible.

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iSpeak Blog
Autonomous Batch Disposition: Transforming Pharmaceutical Manufacturing with Rules, Risk, and AI Signals

Batch disposition remains one of the most important quality decisions in pharmaceutical manufacturing. Before a product can reach a patient, reviewers must confirm that the batch was manufactured, tested, documented, serialized, and controlled according to approved procedures and regulatory expectations. This work protects patients, preserves product quality, and ensures compliance. Yet in...

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iSpeak Blog
Meet Paige Kane, PhD, a 2026-2027 ISPE International Board of Directors Election Candidate

The 2026 ISPE International Board of Directors Election provides members with the opportunity to help shape the future of the Society by voting for representatives to fill open seats on the International Board. The Board plays a critical role in establishing ISPE’s vision and mission, setting strategic priorities, and ensuring that operations align with ISPE policies, best practices, and...

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iSpeak Blog
The Lesson History Teaches About Artificial Intelligence (AI)
In my last blog post, “The Expertise Question that Artificial Intelligence (AI) Cannot Answer,” I explored an important question for the AI era: if today’s experts created the knowledge that powers AI, who will create the expertise that advances knowledge tomorrow?
Beyond The Single System: Why GxP Validation Governance Needs to Catch Up With How We Actually Work
iSpeak Blog
Beyond The Single System: Why GxP Validation Governance Needs to Catch Up With How We Actually Work

When you ask a computer system validation (or assurance) professional to describe their job, they describe their projects. A system implementation, a multi-phase, multi-regional program, or a validation lifecycle for a specific application. That framing is understandable; the guidance documents and quality procedures are organized the same way. Validation of computerized GxP systems is...

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iSpeak Blog
Meet Shanshan Liu, a 2026-2027 ISPE International Board of Directors Election Candidate

The 2026 ISPE International Board of Directors Election provides members with the opportunity to help shape the future of the Society by voting for representatives to fill open seats on the International Board. The Board plays a critical role in establishing ISPE’s vision and mission, setting strategic priorities, and ensuring that operations align with ISPE policies, best practices, and...

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iSpeak Blog
Anticipating the Scale-Up Cliff: A Forward-Looking Yield Framework for Biologics Process Decisions

Bioprocess scale-up rarely follows the smooth saturation curve that yield models implicitly assume. As a representative illustration of the pattern, a pilot run can deliver 92 percent line yield, while the commercial-scale confirmation run that should deliver roughly 89 delivers 71. Those figures are illustrative of the regime-transition signature rather than a single named plant’s record, but...

Meet Michele Ghinizzini, a 2026-2027 ISPE International Board of Directors Election Candidate
iSpeak Blog
Meet Michele Ghinizzini, a 2026-2027 ISPE International Board of Directors Election Candidate

The 2026 ISPE International Board of Directors Election provides members with the opportunity to help shape the future of the Society by voting for representatives to fill open seats on the International Board. The Board plays a critical role in establishing ISPE’s vision and mission, setting strategic priorities, and ensuring that operations align with ISPE policies, best practices, and...

26-Member-Spotlight
iSpeak Blog
ISPE Member Spotlight: Reflections from Diala Raad, ISPE France Affiliate Student Member, on the 2026 Europe Annual Conference

The 2026 ISPE Europe Annual Conference in Copenhagen, Denmark, which took place in April, brought together students, recent graduates, practitioners, and industry experts from across the globe to explore the future of pharmaceutical science, engineering, and innovation. For Diala Raad, a pharmacy student at the University of Bordeaux and an active member of the ISPE France Affiliate, the...

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iSpeak Blog
What 21 CFR Part 11 §11.10(e) Actually Requires of an Audit Trail—and Why Most QMS Implementations Stop Short

For a clause that has been in force since 1997, 21 CFR Part 11 §11.10(e) is still remains one of the most under-implemented requirements in computerized GxP systems. Many quality and information technology (IT) teams reduce it to a single compliance checkbox: "we log who changed what, with a timestamp—done." But when an inspector looks beyond that surface-level interpretation, the gaps quickly...

26-Member-Spotlight: Thomas Vignals
iSpeak Blog
ISPE Member Spotlight: Reflections from Thomas Vignals, ISPE France Affiliate Student Member, on the 2026 Europe Annual Conference

For students and emerging professionals in the pharmaceutical industry, opportunities to engage with global leaders, explore cutting-edge innovations, and build meaningful connections can be transformative. The 2026 ISPE Europe Annual Conference is one such opportunity; bringing together experts, innovators, and the next generation of talent to exchange ideas and shape the future of the...

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iSpeak Blog
Artificial Intelligence (AI) Implications for Facility Design

The idea for this blog post arose from attending the 2025 Venice Architecture Biennale, themed "Intelligens. Natural. Artificial. Collective." Recently, in fact, scientific dialogue has pivoted significantly towards sustainability, aiming to reduce carbon footprints and increase awareness.

Member Spotlight: Neha Pandya
iSpeak Blog
Member Spotlight: Neha Pandya on Connection, Collaboration, and the Power of ISPE

ISPE announced a remarkable milestone at the 2025 ISPE Annual Meeting & Expo, celebrating 45 years of innovation, surpassing 25,000 global members, and reaching more than 100,000 followers on LinkedIn. These achievements reflect the strength of ISPE’s global community and the collective impact of professionals dedicated to advancing pharmaceutical engineering and improving patient...

Validation 4.0 and the Shift Toward Continuous Control
iSpeak Blog
Validation 4.0 and the Shift Toward Continuous Control

Validation in the pharmaceutical industry has long been treated as a fixed milestone: something to complete, document, and file away. But as digital technologies reshape how products are developed and manufactured, that model is increasingly showing its limits. In

Sponsored content is the sole responsibility of the authors and is not endorsed, reviewed, nor a published article of Pharmaceutical Engineering® magazine or ISPE.

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Sponsored Content
Annex 1: Solutions in Environmental Monitoring

Environmental monitoring compliant with GMP regulations is mandatory for aseptic fill-and-finish processes under Grade A conditions. Conventional monitoring using petri dishes still results in numerous glove interventions - something that should be avoided under GMP Annex 1 wherever technically feasible alternatives exist. This article presents equipment engineering solutions that enable users...

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Sponsored Content
2026 State of Validation Report

Unlock the latest insights and trends in validation practices with the 2026 State of Validation report — now in its fifth year. Independently authored by Donncadh J. Nagle, Senior CQV Consultant at Jacobs Engineering and Lecturer at Technological University Dublin, the State of Validation comprises a broad quantitative and qualitative primary market research study, conducted directly with...

Current Issue

Pharmaceutical Engineering

May / June 2026

This issue explores the evolving landscape of Advanced Therapy Medicinal Products (ATMPs), examining how innovation across science, manufacturing, and strategy is shaping the path to patients.