Featured Articles

Features
Continuous manufacturing (CM) offers one way the pharmaceutical industry can accelerate development of the drug product control strategy to ensure a robust and reliable supply of medicine to the clinic and/or market. This article explores the promise of continuous manufacturing in enhancing...
Features
Application of continuous manufacturing (CM) in the pharmaceutical industry is gaining momentum. Most of the current experience is based on oral solid dosage (OSD) projects but in the future continuous manufacturing should not be limited to these dosage forms. In this article, the regulatory...
Features
The ISPE OSD Community of Practice Continuous Manufacturing Subcommittee is planning a Good Practice Guide to capture information developed over several years by the team to establish equipment requirements, identify opportunities for harmonization and flexible integration, and suggest where...
Features
Cell and gene therapies are complex. As more therapies come to market in the hope of bringing advanced treatments and cures to rare, orphan, and difficult-to-treat diseases, designing quality standards for these personalized medicines is equally as complex.European Commission. EudraLex, Volume 4:...
Technical
Powder for oral suspension (PfOS) bioavailability is mostly on the basis of drug absorption from the gastrointestinal tract. PfOS formulation pH, viscosity, vehicle buffer capacity, drug particle size distribution, density, and viscosity are often critical for absorption. Therefore, careful design...
Technical
Since 2019, the ISPE France Affiliate’s Unique Device Identification (UDI) Medical Device Work Group has been producing tools to help project stakeholders within the EU or overseas understand and comply with EU regulations of UDIs in medical devices. Some of those tools are highlighted in the...
Technical
Software as a medical device (SaMD) is software intended to be used for one or more medical purposes without being part of a medical device.International Medical Device Regulators Forum. “Software as a Medical Device (SaMD): Key Definitions.” 9 December 2013....
Features
This second of a two-part series explores digital transformation and digitalization in the biopharmaceutical industry with information about how data science enables digitalization along the product life cycle. (Part 1 was published in the March-April 2021 issue of Pharmaceutical...
Features
Cloud computing can be described as networked access and utilization of configurable computing resources such as data and information storage, processing capabilities, applications, and other services on computerized systems provided and/or maintained by a remote organization. As life sciences...
Features
In 2021, the ISPE GAMP® Community of Practice (CoP) is celebrating 30 years of promoting industry good practice for computerized systems and encouraging technical innovation and progress, while protecting patient safety, product quality, and data integrity.
Features
Real-world evidence (RWE) is clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD) relating to patient health status and the healthcare delivery.US Food and Drug Administration. “Use of Real-World Evidence to...
Features
The fourth Industrial Revolution (also known as Industry 4.0) is the era of smart machines, storage systems, and production plants that can autonomously exchange information, trigger actions, and control operations free of any human intervention. To ensure future success in the delivery of...
Features
Digital transformation and digitalization are on the agenda for all organizations in the biopharmaceutical industry. But what are the main enablers of intelligent manufacturing? We hypothesize that data science–derived manufacturing process and product understanding is the main driver of...
Features
During the ISPE Pharma 4.0™ Virtual Conference, the Management Communication working group of the ISPE Pharma 4.0™ Special Interest Group (SIG) held a workshop to support ISPE members in pitching, shaping, and presenting a Pharma 4.0™ project/program to company management.
Features
Across every industry today, digitalization is driving the use and value of data to disrupt traditional business models and ways of working. In pharmaceuticals, the promises of Industry 4.0 are expected, and needed, to finally modernize the legacy approaches that have evolved since the 1970s....
InTouch
The ISPE Aseptic Conference will celebrate its 30th year with the virtual conference on 15–17 March. The conference has been setting the pace for the evolution of sterile manufacturing processes and technologies in the pharmaceutical industry. This year’s virtual conference platform is providing a...
Features
A fundamental GMP requirement is that processes, systems, and methods used to produce medicines and treatments are validated, meaning their fitness for a purpose is demonstrated. If Industry 4.0 is to succeed in the pharma space as Pharma 4.0™, we need new paradigms for validation across the value...
Features
Through this difficult time of the COVID-19 pandemic, ISPE has remained active. At the 2020 ISPE Pharma 4.0™ Virtual Conference, 17–18 November, 174 attendees gathered online to discuss and learn about the progress of the pharma-specific industry 4.0 approach, Pharma 4.0™ (now a registered...
Features
ISPE has announced the launch of its Advancing Pharmaceutical Quality (APQ) Program with the publication of the ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System, a guide dedicated to the topic of CAPA. This article describes how the APQ Program has been built and summarizes the...
Features
This article describes the Pharmaceutical Equipment Exposure Measurement Database (PEEM-DB), which was launched in July 2019 by the ISPE Japan Affiliate for its members. PEEM-DB is offered as a tool for rationally advancing optimal containment equipment settings by collecting exposure measurement...
Features
Personnel management is the most challenging variable in maintaining current Good Manufacturing Practice (cGMP) across the life cycle of drug manufacture, safety, and supply. A standard operating procedure (SOP) outlines agreed-upon instructions for personnel training and instructions for...
Features
Drug developers know that the odds of anyone compound demonstrating safety and efficacy for a disease and its affected populations are low. How can drug developers improve these odds and increase the efficiency and effectiveness of drug development? One useful tool is model-informed drug...
Technical
Recently, recalls of angiotensin receptor antagonists, particularly valsartan, and warning alerts about N-nitrosodimethylamine (NDMA) impurities in drug substances such as ranitidine and metformin have demonstrated the urgent need for manufacturers and regulators to control impurities throughout...
Technical
Online water bioburden analyzers (OWBAs) are analytical instruments providing real-time or near real-time measurement of bioburden in purified water systems.Cundell, A., O. Gordon, N. Haycocks, et al. “Novel Concept for Online Water Bioburden Analysis: Key Considerations, Applications, and Business...

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Latest Articles

iSpeak Blog
The life sciences industry is experiencing a real estate gold rush. Already prosperous, pre-pandemic, life sciences construction surged dramatically when the COVID-19 vaccines rapidly expanded the need for administrative, research and development, and manufacturing spaces in the biotechnology...
iSpeak Blog
Vaccine Manufacturing Innovation Awareness of the pharmaceutical industry has increased significantly in the last 15 months due to the global pandemic. Vaccine manufacturing is now in the spotlight more than ever before. The issues of production output, supply chain shortages, and cold chain...
iSpeak Blog
The past year has been unprecedented for the manner in which the world’s population has adapted to living with the changes brought about by COVID. The life sciences sector has always been to the fore at unleashing scientific innovation to make life better for humanity, and that creativity went into...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from June 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
iSpeak Blog
COVID-19 has caused disruptions and delays with supply chain all across the world. Single-Use technologies (SUT) play a vital role in manufacturing of pandemic vaccines and have drastically reduced the typical vaccine development and manufacturing production timelines. The pandemic has further...
iSpeak Blog
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are suggested summer reading ideas—articles on important topics from recent issues to revisit when you have some down time this summer—or to enjoy for the first time in case you missed them. Learn more about...
iSpeak Blog
I’m from the past, but to some degree, we all are. A number of years ago, I received my Bachelor’s degree in mechanical engineering and a desire to make the world a better place. I joined the pharmaceutical industry with that goal in mind. 30 years later, I have that same desire, but the industry...
iSpeak Blog
In the global business environment, advancements in technology and digital platforms are changing how business operations are being carried out. The big data explosion has ensured that business and the digital platform become synonymous to enhance the productivity and efficiency of...
iSpeak Blog
John Clarke works with Pfizer in Dublin, Ireland and is currently the Process Lead on a facility expansion project for conjugate vaccine manufacture. John graduated from University College Cork with a Bachelor of Science in Microbiology and earned a Masters of Engineering Science in...
iSpeak Blog
What a year to be agile for collaboration and innovation! Our industry has been driving unprecedented success for patients this year, which is fitting for the 2021 ISPE Annual Meeting & Expo theme, “Agility. Collaboration. Innovation.”
InTouch
The pharmaceutical industry in Spain and Portugal is growing, and the ISPE Iberia Affiliate—which has merged the Spain and Portugal Affiliates to take advantage of synergies between the two Affiliates—is working to train and support this expanding market.
Insights
Optimism is in the air as we move through the summer months and the restrictions that have become second nature are slowly lifting. As I continue the second half of my year as the Emerging Leaders (EL) Chair and representative on the ISPE International Board of Directors, I realize that my...
Insights
Remembering the “why” of our pharma industry is so important and, for me, also very personal. My sister Linda was 69 and her four grandchildren were the light of her life. In November 2017, she was diagnosed with appendix cancer (a rare cancer, closely related to colon cancer). After four months of...
Insights
Organizations wanting to ensure the well-being and growth of their employees need to invest in robust mentorship and recognition programs. Mentoring has played a key role in my career development. In the 1990s and early 2000s, I worked in Novartis and engineering services companies where I was part...
iSpeak Blog
Heating, Ventilation, and Air Conditioning (HVAC) systems are critical systems that can affect the ability of a pharmaceutical facility to meet its objective of providing safe and effective products to patients. In this iSpeak blog post, we talk with leading expert Norman Goldschmidt, President,...
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from May 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
iSpeak Blog
There are two different sides of confidence which I would like to discuss here: the idea of confidence in the workplace and confidence in oneself.
iSpeak Blog
The issue of data integrity may appear archaic in a highly connected, digital world. Yet many within the pharmaceutical industry it continues – be it intentional or not – to fall foul of regulators tasked with auditing businesses’ practices. Peter Cusworth at Yokogawa examines an age-old problem,...
Online Exclusives
The 30th ISPE Aseptic Conference culminated in the interactive regulatory panel, which offered attendees the unique opportunity to ask questions directly to the regulators.
iSpeak Blog
The wait is over… The 2021 ISPE Annual Meeting & Expo is back and will be held in Boston, Massachusetts, at the Hynes Convention Center and Sheraton hotel from 31 October–3 November. This year’s conference theme, ‘Agility. Collaboration. Innovation.’, truly represents how our industry has responded...
iSpeak Blog
I am excited to share with you that the first “Face to Face” ISPE Conference since the beginning of COVID-19 is now scheduled to take place in North Bethesda, Maryland, USA, on 28–29 September. The 2021 ISPE Facilities of the Future Conference will be an in-person, live event full of topics of...
iSpeak Blog
Thomas Hartman, ISPE’s President & CEO and active ISPE Member for over 20 years, speaks with us on his favorite ISPE memories, his real-world examples on the benefits of ISPE, and why volunteering is so important. Join us as we get to know Thomas a little more.
iSpeak Blog
Dr. Randy Perez retired from the position of Director of Information Governance and Management for Novartis Pharmaceuticals in 2015. During his 32-year tenure at Novartis his responsibilities included a wide range of IT Compliance issues, such as GxP, Sarbanes-Oaxley, and data privacy. He served on...

Current Issue

July / August 2021

Opportunities in Continuous Manufacturing of Large Molecules Cover: Continuous manufacturing has attracted signi cant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biologic products such as vaccines) would, in principle, be even more justi ed for both...