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
ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The pharmaceutical...
iSpeak Blog
Pharmaceutical Engineering® magazine is proud to announce the 2020 Roger F. Sherwood Article of the Year is “Implementation of a Formal Energy-Efficient Design Process” (Mar-Apr) by Aoife Hamill, BE MSc, John Hanley, PhD, MPhil, CEng, and Vincent Lane.
iSpeak Blog
The strength of ISPE’s global network of Affiliates and Chapters is critically important in achieving ISPE’s mission to be the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights to...
iSpeak Blog
Apply for an ISPE grant to attend the 2021 ISPE Annual Meeting & Expo and a one-year ISPE Membership. If you have less than five years of experience in the pharmaceutical or life sciences industry, you could be eligible to receive a grant to attend the 2021 Annual Meeting & Expo in Boston,...
iSpeak Blog
Pharmaceutical Engineering® is delighted to announce the finalists for the 2020 Roger F. Sherwood Article of the Year Award. The articles were selected by the judges from 35 feature and technical articles published in PE during calendar year 2020 (Volume 40).
iSpeak Blog
Introduction The U.S. Food and Drug Administration (FDA) has announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT). This is a significant step in the FDA’s technology and data...
iSpeak Blog
This week ISPE released The ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management. The first such guidance to discuss critical thinking, agile and IT service management in relation to the life sciences industry, the Guide seeks to apply ISPE GAMP® 5...
iSpeak Blog
Pharmaceutical Engineering® magazine is proud to announce the 2019 Roger F. Sherwood Article of the Year is “Regulating Online Pharmacies and Medicinal Product E-Commerce” (Nov-Dec 2019) by Sia Chong Hock, Mervyn Ming Xuan Lee, and Lai Wah Chan.
iSpeak Blog
The needs of patients must always be at the forefront of what we do. Many of our colleagues are taking on the challenge of rethinking the old ways. They are collaborating with each other and the regulatory agencies to take effective steps to remain at the forefront of regulatory science and...
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
Pharmaceutical Engineering® is delighted to announce the finalists for the 2019 Roger F. Sherwood Article of the Year Award. The articles were selected by the judges from 35 feature and technical articles published in PE during calendar year 2019 (Volume 39).
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...

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...