Is a Globally Harmonized Quality Overall Summary Possible?
Is a Globally Harmonized Quality Overall Summary Possible?
Features
– The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4)1 offers advantages in the consistent format of the registration dossier using the Common Technical Document (CTD). However, it does not deliver a...
  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality–M4Q (R1) Quality Overall Summary of Module 2 Module 3: Quality.” Published 12 September 2002. https://database.ich.org/sites/default/fi les/M4Q_R1_Guideline.pdf

Featured Articles

Regulatory Landscape for Raw Materials: CMC Considerations
Features
Regulatory Landscape for Raw Materials: CMC Considerations
A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Therefore, there is an increasing need to implement a harmonized regulatory infrastructure that is both flexible and predictable to provide more...
Figure 1: Redundancies in the postapproval change management process contribute to delayed approval.
Features
Streamlining Postapproval Submissions Using ICH Q12 & SCDM
Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Incorporating concepts and tools from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline, combined with structured content and data management (SCDM) and a cloud-based data exchange...
Figure 1: Stage 3 of the Validation 4.0 model focuses on continuous verification as a targeted result of QbD.
Technical
Validation 4.0: Case Studies for Oral Solid Dose Manufacturing
Three case studies on Validation 4.0 demonstrate how quality by design (QbD) principles, when applied with digitization, can verify processes in scale-up and technology transfer, and why blend and content uniformity matter for tablet integrity.
Figure 1: Oxygen piping system decontamination connections.
Technical
Novel Dry Decontamination Method Using Gaseous Chlorine Dioxide
Chlorine dioxide has been shown effective in decontaminating various types of chambers and volumes such as rooms, isolators, processing tanks, and entire facilities, but its use to decontaminate compressed gas piping systems has not been documented. This article discusses using dry gaseous chlorine dioxide (ClO2) to decontaminate an oxygen (O2) feed piping system in a...
From Data to Knowledge Management: What to Consider
Features
From Data to Knowledge Management: What to Consider
Although data and knowledge are both stand-alone disciplines that need to be systematically managed, they also must have a connection. Understanding the relationship between data and knowledge management processes and how people are leveraging advances like Pharma 4.0™ combined with these processes enables quality data transition to knowledge that can help pharmaceutical companies. The authors...
Effective Knowledge Management in Mergers and Acquisitions
Features
Effective Knowledge Management in Mergers and Acquisitions
As the pharmaceutical industry continues to grow and evolve, a significant contributor to innovation and evolution is mergers and acquisitions (M&A). M&A can enable academic researchers and small companies to fund and commercialize innovative products. In addition, M&A can help larger organizations secure new and complementary technology and products. In the pharmaceutical...
Knowledge Centers Improve Knowledge Capture and Sharing
Features
Knowledge Centers Improve Knowledge Capture and Sharing
As the industry experiences significant changes to the way we do business, knowledge capture and sharing are more important now than ever before. The maturing digitalization of the biopharma industry’s business and processes is creating an increasingly data- and information-rich environment that requires more effective mechanisms for sharing data and information. The Knowledge Management team...
Reimagining CPV for a Pharma 4.0™ World
Features
Reimagining CPV for a Pharma 4.0™ World
The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing process verification (OPV).1
  • 1US Food and Drug Administration Center for Drug Evaluation...
FOYA Winners Share Lessons Learned in Facilities Development
Features
FOYA Winners Share Lessons Learned in Facilities Development
What do recipients of ISPE’s prestigious Facilities of the Year Award (FOYA) know that has helped their projects succeed? What are the lessons learned from achievements in facilities development, including forward-looking projects that encompass and inspire changes in the industry? Pharmaceutical Engineering® spoke with nine FOYA winners from recent years about the lessons they learned and...
Pandemic Progress: Industry’s Journey From 2020 to Today
Special Reports
Special Report: Pandemic Progress: Industry’s Journey From 2020 to Today
In 2020, the world was grappling with how to slow the spread of the SARS-CoV-2 virus and appropriately treat people who had the COVID-19 infection without approved therapies or vaccines. In two years, there are multiple vaccines and treatments along with great knowledge about the virus—and about how the industry mobilized, partnered, and achieved tremendous strides in addressing the global...
Special Report: Operation Warp Speed: A View From the Inside
Special Reports
Special Report: Operation Warp Speed: A View From the Inside
Operation Warp Speed coordinated US government support of the pharmaceutical industry’s effort to develop and deliver vaccines and therapeutics across the United States to fight the COVID-19 pandemic. This article provides an inside look at the work done by this team to address the threat posed by COVID-19.
Figure 3: Industry develops a single global control strategy.
Features
Toward a Single Global Control Strategy: Industry Study
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 geographic regions. This article shares data that highlight instances where well-established ICH...
Figure 3: Adoption time in years experienced by nonpharmaceutical and pharmaceutical industries since the technologies were invented/discovered.
Features
Measuring Pharma’s Adoption of Industry 4.0
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 sector in general,1
  • 1Singh, P., S. N. Singh, and L. Ram. “Health 4.0: Role of Health...
Figure 1: The 4 Ps of the pharmaceutical value chain are interconnected. Each element finds its virtual representation in a digital twin (figure © Zeta).
Features
Driving Biopharma Solutions with Digital Technologies
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 provides support in drug development, process scale-up, and manufacturing. Furthermore, it accelerates...
Figure 1: Potency assay blind control Xbar-S chart.
Technical
Risk-Based Continued Test-Method Performance Verification System
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 needed.1
  • 1Snee, R. D. “Crucial Considerations in Monitoring Process Performance and...
Figure 3: AUC used as the metric evaluator for models 1 to 5 (2020 data) and model 1 (2018 data, bottom right).
Technical
Case Study: Water for Injection Plant AI-based Maintenance
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 plant for preventive maintenance activities, common in the industry, and use a more scientific...
Comparison between autologous therapies and allogeneic therapies
Features
Supporting Scalable Cell Therapy Using Allogeneic Workflows
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. With advancements in manufacturing, developers are becoming increasingly interested in...

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Understanding the Deactivation Capabilities of Hydrogen Peroxide: Bacillus Atropheaus vs Geobacillus Stearothermophilus
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Understanding the Deactivation Capabilities of Hydrogen Peroxide: Bacillus Atropheaus vs Geobacillus Stearothermophilus
This article analyzes the hydrogen peroxide deactivation kinetics of representative bioburden in the pharmaceutical, healthcare and food industries, as well as the role of microbial and process variables, such as, type of microorganism (Geobacillus stearothermophilus or Bacillus atrophaeus), temperature, or particle distribution impact over the deactivation process. In addition, the effect of...
Lonzo
White Paper — Sponsored Content
Building a Business Case for a Digitalized QC Platform
Investing in automated, paperless solutions is a logical step in driving laboratory productivity, reducing costs, and enhancing regulatory compliance. Any laboratory manager working with paper-based systems will have experienced the challenges they present, and as laboratories come under increasing pressure to do more with less, the case for digitalization grows. within the wider organization,...
Determine the right dust collection equipment for tablet press applications
White Paper — Sponsored Content
Determine the right dust collection equipment for tablet press applications
Though tablet compression does not generate large volumes of fugitive dust, safe and efficient collection of whatever dust is created by this process is critical in achieving the widely held goal of “error-free performance.” A tablet press depends on a delicate balance of specified airflow and static pressure, climate control, precise material handling and compression force to run properly....

Latest Articles

ISPE BeNeLux PM CoP: Need for Speed in Pharma
iSpeak Blog
ISPE BeNeLux PM CoP: Need for Speed in Pharma
On 16 June 2022, the Project Management Community of Practice Benelux (PM CoP Benelux) hosted the “Need for Speed in Pharma,” event. There were more than 70 attendees at the event from Belgium and the Netherlands which was held at the MSD Animal Health facility in Boxmeer, Netherlands.
Janssen Pharmaceuticals
iSpeak Blog
Meet the 2022 FOYA Social Impact Category Winner: Janssen Biologics
Winners in this category exemplify application of novel approaches, standards, and practices which result in efficient processing, resourceful utilities, and business advantage by increasing patient access and preventing drug shortages through in-country-for country manufacturing; outbreak, epidemic, or emerging health crisis response via rapid deployment and fast-track drug production; and...
Annex 1 Implementation Strategies
iSpeak Blog
Annex 1 Implementation Strategies
Annex 1 of the EC GMP Guide "Manufacture of Sterile Medicinal Products" has a long history. First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015. The first draft for comments from industry stakeholders was...
ISPE GAMP® 5 Guide
iSpeak Blog
Why We All Need Critical Thinking
It may seem that the only things loved by pharma industry more than acronyms are new buzz phrases. And that may be true. But sometimes, behind the buzz phrase, there are real, strong, achievable benefits to our work, our industry, and our end patients.
Survey: How does your Company Dispose of Single-Use Assemblies?
iSpeak Blog
Survey: How Does Your Company Dispose of Single-Use Assemblies?
Single-use plastics are critical for healthcare, life sciences laboratories, and bioprocessing. They have many benefits over other materials and their use is increasing. In particular, single-use technologies for bioprocessing decrease costs, reduce water and energy usage, and increase efficiency and scalability. However, most of these high-value, virgin materials end up in landfills and...
The Next Horizon for Therapy Innovations
iSpeak Blog
The Next Horizon for Therapy Innovations
The industry is continuously evolving to meet new requirements. Many of these requirements include adhering to global regulatory harmonization, improving supply chain robustness, minimizing drug shortages, reducing the complexity of managing product life cycles, and reducing the environmental impact of pharmaceutical processes. At the
CRISPR Therapeutics
iSpeak Blog
Meet the 2022 FOYA Innovation Category Winner: CRISPR Therapeutics
Winners in this category exemplify the novel application of process manufacturing techniques, innovative design concepts, new technologies and unique solutions that exemplify the next generation of agile, flexible, efficient and effective new and existing pharmaceutical and biotechnology facilities. This includes implementation of commercially available and custom developed equipment which...
ISPE Briefs: Volunteer Week 2022: A Success
InTouch
ISPE Briefs: Volunteer Week 2022: A Success
ISPE has more than 19,000 members from more than 129 countries, and many of them spend countless hours sharing their knowledge and connecting with others, helping ISPE to advance the educational and technical efficiency of all members.
Emerging Leaders Editorial - Heather Bennett-Kelley
Insights
Emerging Leaders Editorial: Building Consensus
Most people in their careers have to work with others at some point, and in these work interactions there are exchanges of ideas. In pushing business processes forward, determining methodology for a new experiment, or designing a manufacturing facility, multiple stakeholders come from different points of view and with varying priorities. Working with others in any capacity and having the exact...
Message From the Chair - Jörg Zimmermann
Insights
Message From the Chair: Heading Toward a New Annex 1 and ISPE Annual Meeting
Summer is over and we are all back to our workplaces. This year has been different than the two previous years with vaccination against SARS-CoV 2 decoupling the infection rates from hospitalization, intensive-care units, and fatalities. That is an unprecedented achievement in such short time, and we as the pharmaceutical industry have helped make it happen to get back to a new normal.
Catalent
iSpeak Blog
Meet the 2022 FOYA Social Impact Category Winner: Catalent
Winners in this category exemplify application of novel approaches, standards, and practices which result in efficient processing, resourceful utilities, and business advantage by increasing patient access and preventing drug shortages through in-country-for country manufacturing; outbreak, epidemic, or emerging health crisis response via rapid deployment and fast-track drug production; and...
Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
iSpeak Blog
Should Your Company Switch to Continuous Manufacturing?
As the benefits of continuous manufacturing became more apparent in the pharmaceutical industry, companies looked for ways to incorporate the technology into their manufacturing processes. In 2017 The ISPE Oral Solid Dosage (OSD) Community of Practice (CoP) formed a working team to advance the use of continuous manufacturing in the pharmaceutical industry and to increase the long-term...
Make the Most of Your ISPE Membership
iSpeak Blog
Make the Most of Your ISPE Membership
Are you considering joining ISPE? Or maybe you’ve recently joined the society or are a longtime member looking to better understand all the benefits available to you. If so, you’ve come to the right place!
ATMP Regulations - Comparison of EudraLex Part IV with PIC/S Annex 2A
iSpeak Blog
ATMP Regulations - Comparison of EudraLex Part IV with PIC/S Annex 2A
ATMPs are based on genes, cells or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. Often referred to as ‘Personalised Medicine’. A sector of healthcare that is rapidly evolving and expanding with some unique challenges such as microbial contamination and product variability. Traditional manufacturing processes are for synthetically derived...
GAMP® 5 Second Edition is Here!
iSpeak Blog
GAMP® 5 Second Edition is Here!
GAMP® 5 Second Edition is here! Since its publication, GAMP® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance, and it was time to update our guidance to...
ISPE holds “Expert Xchange: Regulatory Summit on ICH Q9 Revision”
iSpeak Blog
ISPE holds “Expert Xchange: Regulatory Summit on ICH Q9 Revision”
“Are you ready to implement the updated ICH Q9(R1)?” That question was at the heart of the of ISPE’s “Expert Xchange: Regulatory Summit on ICH Q9 Revision” held 9 June 2022. Seventy-one participants from 14 countries discussed ICH Q9(R1) and received valuable insight from several members of the Expert Working Group (EWG) assembled in 2020 to lead the ICH Q9 revision process....
Janssen Leiden VLF expansion
iSpeak Blog
Meet the 2022 FOYA Project Execution Category Winner: Janssen Biologics
Winners in this category exemplify the application of novel tools and approaches to delivering projects that improved efficiencies, overcame unusual challenges, promoted effectiveness, and organized stakeholders and project team participants in ways that led to successful outcomes such as efficiency, delivery, quality, product yield, consistency, and cost of goods.
Today’s Biomanufacturing Options Build, Broker, or Blend
Sponsored Content
Today’s Biomanufacturing Options Build, Broker, or Blend
Introduction With more than 400 registered gene therapy clinical trials worldwide and a compound annual growth rate of more than 25% since 2015, there is no doubting the impact of cell and gene therapy (CGT) innovation on the market.
Building Reliability into Bioprocessing – How Component Testing Improves Consistent Performance
Sponsored Content
Building Reliability into Bioprocessing – How Component Testing Improves Consistent Performance
Cost of failure has been a consistent topic in bioprocessing for decades, yet the industry still has significant challenges with manufacturing robustness. Bioprocessing manufacturers work to ensure reliability through evaluation of single-use system (SUS) assemblies and individual components, and maintain a presence for suppliers through their evaluation and product qualification process as...
Module Type Package: Turning Visionary Concepts into Reality
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Module Type Package: Turning Visionary Concepts into Reality
Versatile, modular plants are the process industry's response to constantly changing market requirements, and the pharmaceutical industry is no exception. Flexible technical solutions for the automation of modular plants are in high demand to ensure the consistent implementation of modular plant engineering. Achieving consistency means that industry-wide automation standards must be...

Current Issue

Pharmaceutical Engineering

September / October 2022

Is a Globally Harmonized Quality Overall Summary Possible? Cover: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4) offers advantages in the consistent format of the registration dossier using the Common Technical Document (CTD). However, it does not deliver a comprehensive...