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.

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.

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.

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.

Since the US Food and Drug Administration (FDA) introduced the requirement for secure, computer-generated, time-stamped audit trails in 21 CFR Part 11, audit trail functionality has been recognized as a critical component of data integrity.

The COVID-19 pandemic revealed how unprepared the vaccine industry was for such a global health emergency, but also how the industry rose to meet this challenge. The first efficient COVID-19 vaccines approved were based on a new class of vaccines using messenger ribonucleic acid (mRNA) technology.

As facilities become more complex and equipment requirements more demanding, engineers face increasing challenges in ensuring optimal airflow patterns. Fortunately, advanced digital tools such as computational fluid dynamics (CFD) and building information modeling (BIM) are revolutionizing the way cleanrooms are engineered.

Qualification of equipment used in the manufacturing of pharmaceutical products is a critical step in ensuring the production of a product that consistently meets all critical quality attributes. The US Food and Drug Administration (FDA) has stated a shelf temperature mapping, or a shelf temperature uniformity study is an expected step in the qualification of lyophilizers (freeze dryers).

What if your next digital investment did not deliver the transformation you expected? For many pharmaceutical companies, that is the reality.

The rapid rise of cellular therapies is transforming modern medicine and creating new challenges for manufacturers. Unlike traditional biopharmaceuticals, cell-based products demand innovative approaches to aseptic processing, process closure, automation, and scalability.

Chip Bennett, Senior Director at Project Farma, is a Project Management Institute^®–certified Project Management Professional (PMP), recognized industry expert, speaker, and published author. He is a consultant with more than 25 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and has expertise in risk-based commissioning and qualification...

Stephanie White is a pharmaceutical and biotechnology manufacturing leader with more than 23 years of experience helping teams turn high-stakes projects into confident, inspection-ready operations. She now serves as a Commissioning, Qualification, and Validation (CQV) and Operational Readiness Lead at A-Bio, a consulting firm, supporting sterile manufacturing and complex capital programs. Her...

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.

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,...

The pharmaceutical industry’s embrace of digital technologies and sustainability is no longer a competitive advantage, but an operational necessity. As Pharma 4.0™ matures, its integration will be vital for achieving net-zero objectives and achieving pharmaceutical excellence.

Crafting a sustainable packaging strategy for the pharmaceutical industry is complex and requires balancing environmental responsibility with regulatory compliance and operational costs. In this article, we explore the key drivers, challenges, and best practices for developing such a strategy.

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.