Featured Articles

Features
The ISPE Global Pharmaceutical Regulatory Summit, held virtually on 28 April 2021, brought together 11 regulators from different parts of the world to discuss how their approaches to GMP inspections have adapted to the COVID-19 pandemic.
Features
A unique aspect of the pharmaceutical industry is the pairing of innovation and regulation. For nearly two decades, ISPE’s Product Quality Lifecycle Initiative (PQLI®) has worked at the nexus of pharmaceutical manufacturing technology and regulation to bring forward solutions that help advance new...
Features
In its 30-year history, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has covered a wide range of topics to generate quality, safety, efficacy, and multidisciplinary harmonized guidelines. As science advances, issued guidelines are...
Features
ISPE’s Regulatory Affairs function plays a vital role in the Society, which is to build effective relationships with regulators and agencies globally and ensure all members have access to the latest regulatory developments and expectations. These activities are driven by the collective efforts of...
Technical
Any systematic pharmaceutical engineering approach for ensuring vial container closure system (CCS) performance must include choosing qualified container closure system components, the proper pharmaceutical process setup, and applicable testing methods. Container closure integrity (CCI) is an...
Technical
Defining room temperature and humidity limits is a frequent topic of debate when designing and operating pharmaceutical and biotechnology facilities. What are appropriate alarm limits and acceptable durations for an alarm condition? Understanding the source of temperature and humidity requirements,...
Technical
Cleanrooms and controlled contamination environments are increasingly being used across many industrial sectors, including the pharmaceutical industry. An important issue is the operating cost associated with cleanroom energy consumption and, consequently, the identification of applicable energy...
InTouch
The second guide in ISPE’s Advancing Pharmaceutical Quality (APQ) series provides a systematic and proactive approach to quantitatively assessing and advancing leadership systems by evaluating the management responsibilities highlighted in ICH Q10 as well as other key leadership components.
InTouch
Japan’s pharmaceutical market is one of the world’s largest and the ISPE Japan Affiliate is helping its members stay connected and current in the ever-changing pharmaceutical industry.
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....

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Latest Articles

iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from August 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
ISPE is a global industry leader in scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. As a result, ISPE is in a strong position and available to assist the US government, its allies, and like-minded regulatory partners with implementation of...
iSpeak Blog
Imagine a time where medicines are made at your doorstep, where an illness can be treated in moments, storage conditions are a non-issue, quality is built in, and supply chains don’t matter. Your COVID-19 vaccine is manufactured, tested, and available for dosing, all within blocks of your home....
iSpeak Blog
It’s hard to believe we are more than halfway through 2021 and how 2020 is such a distance memory yet so ingrained into our minds it feels like it was yesterday. As COVID continues to be prevalent in society and with our continued focus on life saving medicines we as an industry must maintain our...
iSpeak Blog
Dr. Ferdinando E. Aspesi has been a member of ISPE for more than 29 years. Currently the Chair of the Pharmaceutical Engineering committee, he is also a member of the Delaware Valley Chapter and has been a member of the Global Pharmaceutical Manufacturing Leadership Forum, the PQLI Science and...
Insights
I live in Indianapolis, Indiana, truly a great place to live. It is not difficult to understand why I like Indy so much: humble, down-to-earth people, farming (I grew up on a farm), readily available participant sports, and many spectator sporting event opportunities including football, soccer,...
iSpeak Blog
This year’s ISPE Annual Meeting & Expo will be a combination of in-person presentations and events with virtual access to the presentations for those who cannot yet travel. The importance of information systems for our industry has evolved at an even faster rate. Digitalization is more important...
iSpeak Blog
All it takes is a quick Google search for the terms “carbon footprint and the pharmaceutical sector” to reveal some depressing reading. Results are led by a staggering piece of research from 2019 that states the global pharmaceutical industry is not only a significant contributor to global warming,...
iSpeak Blog
I am very excited to be leading the Supply Chain, Operations, and Packaging Excellence (SCOPE) track this year at the 2021 ISPE Annual Meeting & Expo. Just like its name, this track will cover a wide variety of subject matter and information; delivered by industry subject matter experts. The impact...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 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
“This is the best time to be working in the life sciences industry,” the Keynote speaker said at an ISPE conference several years ago. At the time, I thought to myself, she is so right, this really is the best time to be working in the life sciences industry. Then, no one imagined that the world...
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
ISPE’s second virtual Global Pharmaceutical Regulatory Summit, held on 16 June 2021, brought together regulators from European Medicines Agency (EMA), Australian Therapeutic Goods Administration (TGA), US Food and Drug Administration, and Center for Drug Regulation and Research, FDA Philippines to...
iSpeak Blog
The San Francisco Bay Area Chapter has won numerous ISPE Awards by virtue of their contributions to the pharmaceutical industry. They continue to have their finger on the pulse of the local industry and respond with innovative and educational programs. The Chapter’s Emerging Leaders Committee is...
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...

Current Issue

September / October 2021

A Vision for ICH Q12: Current Experience, Future Perspectives Cover: Management of global postapproval chemistry, manufacturing, and controls changes is a growing challenge for industry with many issues. ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) is a transformative document shaping global regulatory postapproval submissions that will help...