Feature: 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.
Feature: 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 promise both efficiency and robustness.
Feature: 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.
Technical: 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.
Technical: 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.
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.
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.
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.
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.
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.
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.
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).
The pharmaceutical industry continues to advance how commissioning and qualification (C&Q) is executed across the life cycle of facilities, systems, and equipment. ISPE remains at the center of this global movement—strengthening guidance, expanding training, and fostering new forums for knowledge exchange among members worldwide.
What if your next digital investment did not deliver the transformation you expected? For many pharmaceutical companies, that is the reality.
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...
David Estapé, Chair of the 2026 ISPE Europe Annual Conference, provides an overview of how this year’s conference—to be held 20–22 April in Copenhagen, Denmark, and virtually—was designed to truly reflect the current pulse of the pharmaceutical...
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.
Keith Weseli, Conference Chair, gives an overview of a dynamic agenda that includes world-class speakers discussing the latest innovations, regulatory updates, and best practices in aseptic technology. This year’s conference is designed to address the most pressing challenges and opportunities facing the industry.
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Audrey Ballash, Accountant, Accounting team.
The pharmaceutical industry stands at a pivotal moment. Advanced therapy medicinal products (ATMPs), highly potent compounds, and personalized treatments are redefining both clinical promise and manufacturing complexity.
Women in Pharma continues to be a driving force behind ISPE’s mission to advance pharmaceutical science and professionals worldwide.
