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

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iSpeak Blog
Innovating Regulation: Global Perspectives on Modernizing Quality and Good Manufacturing Practices (GMP)

A panel discussion at the 2026 ISPE Europe Annual Conference brought together leading regulators from Europe and the US to explore how regulatory leadership is evolving in an era of rapid technological and scientific change, including digital transformation efforts, GMP modernization, the maturation of quality risk management, and introduction of artificial intelligence (AI). The panel also...

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iSpeak Blog
When AI Meets GxP: A Risk-Based Framework for Continuous AI Validation in Life Sciences

How do you validate a dynamic system? In regulated life science environments, AI is now operational as part of a variety of applications, such as batch disposition assistance, pharmacovigilance signal detection, deviation filtering, and clinical trial data reviews. However, with accelerating deployments, there is an essential question which will need to be addressed: how can we apply current...

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iSpeak Blog
Solving the Large N Fallacy: A Dual-Key Approach to Lifecycle Process Monitoring

As a pharmaceutical process transitions from early commercial launch into mature continued process verification (Stage 3b CPV), the primary goal is to maintain a predictable state of control. During this stage, manufacturers rely heavily on statistical process control (SPC) and run rules to detect process drift.

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iSpeak Blog
From Vision to Impact: Advancing “Educate” as a Measurable Outcome at the 2026 ISPE Facilities of the Future Conference

The 2026 ISPE Facilities of the Future Conference, held this past February in San Diego, CA, USA, was marked by a high level of energy, openness, and thoughtful engagement. Global experts, regulators, academics, students and recent graduates, and industry professionals were actively engaging with each other, from technical discussions and hallway conversations to shared meals and impromptu...

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iSpeak Blog
Beyond Audit Readiness: Building Always-Ready Quality Systems in Life Sciences
In regulated pharmaceutical and life sciences environments, audit readiness has long been a defining measure of quality maturity. Organizations invest significant effort in preparing for inspections by reviewing records, validating documentation, and ensuring that systems align with regulatory expectations. However, as digital transformation reshapes quality operations and regulatory expectations...
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iSpeak Blog
Advancing Commissioning and Qualification (C&Q) Through Quality Risk Management

In today’s pharmaceutical manufacturing landscape, ensuring product quality and patient safety while accelerating time to market has never been more critical. This recent Addendum provides further clarity, practical insights, and implementation recommendations to help organizations optimize their C&Q delivery processes.

What You’re Not Told by AI—and the Consequences
iSpeak Blog
What You’re Not Told by AI—and the Consequences

First-ever US Food and Drug Administration (US FDA) Current Good Manufacturing Practice (cGMP) Warning Letter Citing Inappropriate Use of Artificial Intelligence (AI) in Pharmaceutical Manufacturing

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iSpeak Blog
From Manual to Modern: US FDA's View on 25 Years of Aseptic Processing

Rick Friedman, Deputy Director of the US Food and Drug Administration (US FDA) Office of Manufacturing Quality, opened the 2026 ISPE Aseptic Conference with a frank look at how far pharmaceutical manufacturing has come—and a candid reminder of how much is still at stake.

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iSpeak Blog
Reimagining Regulatory Operations in the Artificial Intelligence (AI) Age

The rapid evolution of AI is reshaping medicine regulation, shifting the technology from exploratory pilots to becoming a structural capability. A keynote presentation by Hilmar Hamann, PhD, Head of the Information Management Division at the European Medicines Agency (EMA), explored the “shifting frontiers” of the current landscape that will define how AI is developed, governed, and trusted...

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iSpeak Blog
Integrating Artificial Intelligence into Inspection Readiness and Regulatory Response Development: A Technical Perspective and Case Study

Regulatory inspections by the US Food and Drug Administration (US FDA) and other global authorities require pharmaceutical manufacturers to demonstrate sustained compliance with 21 CFR Parts 210/211, ICH Q7, EU GMP Annex 1, and related regulatory frameworks. Traditional inspection readiness models are reactive, labor-intensive, and dependent on significant manual documentation review and...

Mentorship as Service: Tatyana Matveeva on Shaping the Next Generation of ISPE Professionals
iSpeak Blog
Mentorship as Service: Tatyana Matveeva on Shaping the Next Generation of ISPE Professionals

Mentorship plays an essential role in sustaining and advancing the life sciences and pharmaceutical engineering industries. As new professionals enter an increasingly complex and specialized field, guidance from experienced practitioners can help transform academic knowledge into real‑world impact. ISPE has long recognized this need, fostering programs that connect students and early‑career...

The Rise of the Artificial Intelligence (AI) Engineer Position Paper
iSpeak Blog
The Rise of the Artificial Intelligence (AI) Engineer

Engineering does not change with press releases, conference declarations, or digital transformation slogans. It changes when the accumulated friction in delivery models becomes too expensive, too slow, and too risky to defend. Said differently, it changes when the inefficiencies that are tolerated quietly become liabilities that can no longer be justified financially, operationally, or...

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iSpeak Blog
Workforce Preparedness and Organizational Readiness Take Center Stage at the 2026 ISPE AI in Life Sciences Summit – Powered by GAMP®

AI is no longer a future concept for life sciences—it is a present-day force reshaping how medicines are developed, manufactured, regulated, and delivered to patients. Yet as AI adoption accelerates, a critical truth has become clear: technology alone is not enough. Sustainable, compliant, and scalable AI transformation depends on people, culture, governance, and organizational readiness.

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iSpeak Blog
Science, Technology, and Spirit: Insights from the 2026 ISPE MAST Showcase

The ISPE Mid-Atlantic Science and Technology Showcase (MAST) in Baltimore, Maryland, USA held on 7 May highlighted the strength, technical capability, and collaborative spirit of the life sciences industry. Hosted by the ISPE Chesapeake Bay Area Chapter at M&T Bank Stadium, the show brought together more than 950 registrants from across the pharmaceutical and biotechnology community for a...

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iSpeak Blog
Inside FUJIFILM Biotechnologies: A Post Event Recap of the Sold Out Facility Tour Following the 2026 ISPE Europe Annual Conference

As a fitting conclusion to the 2026 ISPE Europe Annual Conference, 30 conference attendees took the opportunity to step inside one of the industry’s most advanced biologics manufacturing facilities during a sold out tour of the FUJIFILM Biotechnologies site in Hillerød, Denmark. Held on Thursday, 23 April, the sold-out tour offered attendees an in depth look at how large scale biologics...

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
From Paper to Digital Sterility Testing - Audit-Ready, anytime!

As laboratories move from paper and standalone instruments toward integrated, digital workflows, data integrity and traceability become strategic differentiators. This article examines how a digital QC companion can transform sterility testing by capturing data in real time, unifying instrument and consumables data, and delivering auditable trails that align with ALCOA+ and 21 CFR Part 11....

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.