Featured Articles

Features
During the past decade, industry has experienced a proliferation of regulatory divergence regarding the interpretation and implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (and control strategies) across...
Features
With the rise of new technologies and predictive analytics capable of handling the huge amounts of data within and across existing information systems, Industry 4.0 has been thriving in many sectors, such as industrial automation, financial technology, retail, and semiconductors. But the health...
Features
Developing comprehensive digital solutions is crucial for the entire value creation process for pharmaceuticals. A holistic view of the interrelations of product, production process, and plant is becoming increasingly significant. In this context, the application of model-based technologies...
Technical
Good data are a characteristic of good science. Quality data are arguably more important today than ever before and are considered by many to be a corporate asset because they are used to develop products and processes, control our manufacturing processes, and improve products and processes when...
Technical
This article presents the results of applying artificial intelligence (AI), such as machine learning algorithms, to identifying and predicting anomalies for corrective maintenance in a water for injection (WFI) processing plant. The aim is to avoid the yearly stoppage of the water for injection...
InTouch
ISPE’s Carolina-South Atlantic (CaSA) Chapter serves members from six different states in the US: North and South Carolina, Tennessee, Alabama, Georgia, and Florida, each with their own unique contributions to the pharmaceutical industry.
Features
Historically, cell therapies are used to treat patients with cancer after relapse from other approved treatment modalities, or if no approved treatment is available. However, the introduction of allogeneic cell therapies has created exciting opportunities to broaden access to cell-based treatments....
Features
The process of bringing new drugs and products to market requires creativity, thinking outside the box, and the courage to fail numerous times before making a single discovery. This rings especially true now, as the industry faces the COVID-19 pandemic and doubts about vaccines and therapies...
Features
With so many options for personalizing our lives, is the personalization of medicine far behind? With all the data available, how can the industry bring personalized medicine to patients? This article explores what is currently available and where the pharmaceutical industry can move forward to...
Features
This article revisits the concept of phased engineering, procurement, and construction (EPC) and updates it with risk-based considerations specifically regarding the commissioning, qualification, and validation (CQV) of general life-cycle principles for pharma and biotech projects. Enhancing the...
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...

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Latest Articles

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
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are Online Exclusives. These are PE articles published exclusively on the website; you can always find them here. Here is a selection from the first two years of Online Exclusives on sustainability, drug shortages,...
iSpeak Blog
Continuous Bioprocessing Platform Continuous processing is not new to the pharmaceutical industry. Today, the majority of major pharmaceutical companies at least consider continuous processes when developing new small-molecule entities. In contrast, the biopharmaceutical industry has been slow to...
iSpeak Blog
The ISPE Aseptic Conference is back and in-person for 2022! We have a great line-up of speakers during the two-day conference, and of course, a great group for the Interactive Regulatory Panel. The program committee has been working diligently over the past year to plan and deliver the best...
iSpeak Blog
When most people hear “Facility of the Future,” they immediately think about robots, automation, virtual reality, or logging in with a Facebook account, security issues aside. However, when I hear “Facility of the Future,” I think of lean manufacturing and flexibility. The majority of my career has...
iSpeak Blog
Knowledge Management (KM) is a discipline (akin to Quality Risk Management (QRM) or Lean Six Sigma) that focuses on how organizations create, manage, use, and share knowledge. The publication of ICH Q10 in 2008 saw the formal designation of KM as a key enabler for an effective Pharmaceutical...
InTouch
Since the first edition of the ISPE Good Practice Guide: Good Engineering Practice (GEP) was published in 2008, the pharmaceutical industry and regulators developed industry standards, best practices, and regulatory guidance around topics that relate to Good Engineering Practice, culminating in...
Insights
The past two years have turned things upside down and forced change in a way that has made many aspects of our lives become unfamiliar. The unforeseen stresses of these changes have pushed many people and companies to their breaking points. Some of these challenges were expected, but came on like a...
Insights
ISPE Women in Pharma® (WIP) wants to kick off the new year by focusing on your journey in taking care of your total self. Whether it is your professional or personal mission to better yourself, Women in Pharma® will provide programming and support this year. We are supporting women and men globally...
Insights
Who would have thought at the beginning of the pandemic that we would have several highly effective vaccines against the coronavirus and billions of doses administered by the end of 2021? I am still amazed what we as the pharmaceutical industry have achieved.
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 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
A thought-provoking session held during the 2021 ISPE Annual Meeting & Expo provided insight into how the Overall Quality Summary can provide an ideal opportunity to provide a comprehensive view of the control strategy and discuss patient risk-benefit.
iSpeak Blog
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are some great reading selections for the holidays! This year’s holiday topic: biopharma, cell and gene therapies, and ATMPs. That topic is the theme for the November-December 2021 issue , and here are some earlier...
iSpeak Blog
Competitive advantage and sustained business results depend on leaders building and maintaining a strong culture. This has been reinforced by the increased challenges in attracting and retaining talent. The FDA is also placing significant focus on Quality Management Maturity. But how do leaders...
iSpeak Blog
Vaccine Manufacturing The industry is experiencing an acceleration in the development and approval of novel prophylactic and therapeutic vaccine modalities. Concurrently, many biopharmaceuticals are experiencing the benefits of manufacturing process intensification (PI). Describing such advances...
iSpeak Blog
It is a great honour and pleasure for me as Chair of the ISPE Board of Directors and Chair of the 2022 ISPE Aseptic Conference Program Committee to give you an overview of the upcoming conference including information about the knowledge that will be shared, a look at some of the speakers, and...
iSpeak Blog
Volunteers are the lifeblood of ISPE. Along with staff, they implement the global mission of the Society and produce essential content that benefits the life sciences industry. ISPE values our volunteers’ time and the commitment they make to sharing their knowledge and talents for the good of...
iSpeak Blog
In September 2021, a panel of regulators representing ANSM (France), ANVISA (Brazil), FDA (US), and the WHO participated in a webinar to discuss opportunities for drug shortage prevention. The discussion was facilitated by industry leaders while industry insights were obtained through polling of...
iSpeak Blog
The uncertainty that comes with the introduction of a new idea has affected society for centuries. We all grew up hearing about how sailors of old feared sailing off the edge of the world before we accepted that the Earth was indeed round. Inventors are always ridiculed by naysayers until their...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 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
The ISPE Aseptic Conference is in its 31st year. This year like many others, we have a long list of enigmatic speakers discussing topics that matter to your everyday business. But unlike in years past, we have more to celebrate. After a long period with us pouring our energy into producing the...
iSpeak Blog
Late last month, ISPE published the 2nd Edition of the ISPE Good Practice Guide: Good Engineering Practice. This revision comes a decade and a half after the original guide was published and is the culmination of a year-long effort of a multi-national, cross-functional team of industry experts....

Current Issue

January / February 2022

Emerging Leaders: Nurturing Emerging Talent and the Workforce of the Future Cover: Emerging Leaders has grown from an initiative for interactions among early-career professionals and entering ISPE into much more: a training ground, a networking organization, and a new foundation for the future of ISPE and the industry. This article looks at the history of the group, its purpose, current and future...