A Vision for ICH Q12: Current Experience, Future Perspectives
A Vision for ICH Q12: Current Experience, Future Perspectives
Features
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Management of global postapproval chemistry, manufacturing, and controls (CMC) 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 alleviate some of these issues.

Featured Articles

ISPE Global Pharmaceutical Regulatory Summit Speaker Panel
Features
Distant Assessments, Audits, & Regulatory Guidance
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.
Figure 1: PQLI integration over the product life cycle.
Features
PQLI®: Advancing Innovation & Regulation
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...
Submission and review process diagram
Features
ICH Quality Guidelines: Present Initiatives & ISPE Involvement
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...
ISPE’s Regulatory Affairs function
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ISPE’s Regulatory Affairs function
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...
Figure 4
Technical
Safeguarding Vial Container Closure Integrity: A Systematic Approach
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...
Figure 1: Seasonal comfort (temperature and RH). ©ASHRAE, www.ashrae.org. Used with permission from 2017 ANSI/ASHRAE Standard 55 [4].
Technical
Temperature & Humidity Requirements in Pharmaceutical Facilities
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,...
Figure 1: A HEPA fi lter without a di user (left) and a HEPA fi lter with a di user (swirl di user; right).
Technical
Pharmaceutical Cleanroom Design & ISO 14644-16
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...
ISPE Briefs: New APQ Guide on Management Responsibilities & Review
InTouch
ISPE Briefs: New APQ Guide on Management Responsibilities & Review
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.
ISPE Japan Affiliate: Growing to Meet Market Needs
InTouch
ISPE Japan Affiliate: Growing to Meet Market Needs
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.
Continuous Manufacturing as a Tool for Accelerated Development
Features
Continuous Manufacturing as a Tool for Accelerated Development
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...
Regulatory Aspects of Global Acceptance of Continuous Manufacturing
Features
Regulatory Aspects of Global Acceptance of Continuous Manufacturing
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...
Continuous Manufacturing Good Practice Guide Is Planned
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Continuous Manufacturing Good Practice Guide Is Planned
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...
Navigating the Life Cycle for Cell & Gene Therapies
Features
Navigating the Life Cycle for Cell & Gene Therapies
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:...
Article
Technical
Effect of Gum on in Vitro Dissolution of Powder for Oral Suspension
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...
Medical Device UDI Components Management in the European Union
Technical
Medical Device UDI Components Management in the European Union
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...
Figure 1: Software in healthcare.
Technical
Software as a Medical Device Fundamentals
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....
Effect of Industry 4.0 enablers on the product life cycle.
Features
Data Science for Pharma 4.0™: Drug Development, & Production—Part 2
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...
Functional interface overview.
Features
Cloud Computing Implications for Manufacturing Execution Systems
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...
Happy 30th Anniversary to the GAMP® Community of Practice!
Features
Happy 30th Anniversary to the GAMP® Community of Practice!
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.
Best Practices for Deploying Real-World Evidence Solutions
Features
Best Practices for Deploying Real-World Evidence Solutions
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...
The holistic supply chain
Features
Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0™
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...
Effect of Indutry 4.0 enablers on the manufacturing process chain. Upper arrow: Conventional approach. Lower arrow: Perceived extended process chain using IIoT enablers.
Features
Data Science for Pharma 4.0™, Drug Development, & Production—Part 1
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...
Empathy phase elements identified in the workshop
Features
"How to Pitch and Shape a Pharma 4.0™ Project” Workshop
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.
The History & Future of Validation
Features
The History & Future of Validation
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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Ceiling Airflow Containment and Control
White Paper — Sponsored Content
Ceiling Airflow Containment and Control
The movement of air within a space for the purpose of heating, cooling, and ventilation is fundamental to the design of modern buildings.  Awareness of how air moves within and between spaces is also increasing as designs respond to the COVID-19 pandemic...
How to Speed up Cell & Gene Therapy Treatments
White Paper — Sponsored Content
How to Speed up Cell & Gene Therapy Treatments
How MES systems address cell and gene production problems Our white paper addresses the unique manufacturing challenges in cell and gene therapy and explains how digital solutions such as a manufacturing execution system (MES) can target these...
Comprehensive Pure Water Guide for Pharmaceutical Engineers
White Paper — Sponsored Content
Comprehensive Pure Water Guide for Pharmaceutical Engineers
In today’s pharmaceutical facilities the availability of purified water is essential. This Pharmaceutical Pure Water Guide is a comprehensive resource for engineers and professionals responsible for ensuring a consistent and safe supply of water for use...
Vaccines Production. Challenges and Trends in Vaccine Manufacturing
White Paper — Sponsored Content
Vaccines Production. Challenges & Trends in Vaccine Manufacturing
A Journey through Vaccines’ History, Highlighting Steps And Equipment Involved in Their Complex Aseptic Production Process Vaccines manufacturing involve a complex aseptic production process that has been challenged in the current pandemic times....

Latest Articles

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ISPE Member Benefit from Networking Opportunities
There are many benefits to networking. In addition to strengthening business connections and meeting new people, it can help you discover new ideas and gain a fresh perspective on topics in the life sciences and pharmaceutical industries. It can help you advance your career and learn about new...
ISPE Accelerating Digital Transformation with Pharma 4.0 Initiative
iSpeak Blog
ISPE Accelerating Digital Transformation with Pharma 4.0 Initiative
ISPE’s Pharma 4.0™ initiative provides guidance, aligned with the regulatory requirements specific to the pharmaceutical industry, to accelerate Pharma 4.0™ transformations. Also known as the Smart Factory, the objective of Pharma 4.0 is to enable organizations involved in the product lifecycle to...
Building construction
iSpeak Blog
Building with Benchmarks: How Modern Techniques Can Cut Construction Time & Costs
One of the most significant changes to the pharmaceutical industry in the last decade has been the increased speed in developing new therapies. A striking example of this is the rapid rollout of the COVID-19 vaccines. What usually took 10-15 years was researched, developed, and put into production...
How Knowledge Management Can Improve Quality and Increase Efficiency
iSpeak Blog
How Knowledge Management Can Improve Quality and Increase Efficiency
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...
Roger F. Sherwood Article of the Year Award
iSpeak Blog
Pharmaceutical Engineering® Announces 2020 Article of the Year
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.
ISPE’s “One ISPE” Initiative to Boost Chapter & Affiliate Growth
iSpeak Blog
ISPE’s “One ISPE” Initiative to Boost Chapter & Affiliate Growth
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...
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iSpeak Blog
Are You a Recent Graduate?
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,...
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iSpeak Blog
2020 Roger F. Sherwood Article of the Year Award Finalists Announced
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).
GAMP Good Practice Guide: Enabling Innovation
iSpeak Blog
FDA IT and Data Modernization Efforts and Technological Innovation
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...
New ISPE GAMP® GPG Supports Innovation in Life Sciences Industry
iSpeak Blog
New ISPE GAMP® GPG Supports Innovation in Life Sciences Industry
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...
Roger F. Sherwood Article of the Year Award
iSpeak Blog
Pharmaceutical Engineering® Announces 2019 Article of the Year
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.
Agility & Innovations in Process Development and Manufacturing
iSpeak Blog
Agility & Innovations in Process Development and Manufacturing
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...
ISPE Member Spotlight: Andria Thomas
iSpeak Blog
ISPE Member Spotlight: Andria Thomas
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...
2019 Roger F. Sherwood Article of the Year Award
iSpeak Blog
2019 Roger F. Sherwood Article of the Year Award Finalists Announced
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).
Read, Learn, Innovate: Top Blog Posts from August 2021
iSpeak Blog
Read, Learn, Innovate: Top Blog Posts from August 2021
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.
AAAA framework
iSpeak Blog
ISPE Initiatives Support Supply Chain Resiliency
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...

Current Issue

Pharmaceutical Engineering

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...