Catherine Hall is Chair of the Investigational Products, North America (IPNA) Community of Practice (CoP) Steering Committee and is one of the authors of the ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices. She has been a member of ISPE for 18 years.

The pharmaceutical industry began applying the principles of continuous processing to the manufacture of oral solid dosage (OSD) forms in the mid-2000s. The consensus among experienced practitioners is that the continuous approach has numerous benefits. “Continuous manufacturing provides for a full range of product life cycle, from small volume clinical production to large volume commercial...

Heather Watson has been a member of ISPE for 22 years. She is Chair of the GAMP^® Global Steering Committee and has been a recipient of the ISPE Committee of the Year Award on three occasions, and was Co-Chair of the ISPE 

Christian Wölbeling has been a member of ISPE for 25 years. A founding member and current Chair of ISPE’s Pharma 4.0™ Community of Practice (CoP) Steering Committee, Christian has also been very involved with the GAMP^® and Process Analytical Technology CoPs, as well as the ISPE Germany/Austria/Switzerland (D/A/CH) Affiliate.

The United Kingdom Emerging Leaders Awards program is an exciting initiative for ISPE because it recognizes and celebrates the efforts and contributions of young engineers in the United Kingdom pharmaceutical engineering and manufacturing sectors.

“Over the past 20 years, there have been an increasing number of highly potent materials handled within the pharma industry, to the point where most modern products require some degree of containment or other exposure control to maintain safety,” said guide team member Peter Marshall, AstraZeneca (retired).

The event, organized by and for recent graduates and students by the ISPE Emerging Leaders Community of Practice (CoP), offered high-quality presentations and interactive workshops where participants...

As Head of Merck’s Global Manufacturing Operations and one of the most senior operations leaders in Merck, Sanat is responsible for Merck’s worldwide manufacturing operations and product supply, supporting global sales revenue of over $55 billion.

Roujian “RJ” Zhang is Chair of ISPE’s new Quality Control (QC)/Analytical Community of Practice (CoP) Steering Committee. He is also Chief Quality Officer at Evive Biotech, responsible for all aspects of quality for the company, ensuring safety and efficacy, making critical quality decisions, and keeping the company up to date with new regulations. RJ became interested in the pharmaceutical...

Terry Jacobs is Chair of the Oral Solid Dosage (OSD) Community of Practice (CoP) Steering Committee. He is a recognized expert in the design of pharmaceutical, biotechnology, and corporate facilities and has completed projects for clients in the US, China, Mexico, and Saudi Arabia. He has lectured extensively on the planning and programming of laboratories and manufacturing and other...

Cultural excellence is the expressed and implied ways in which an organization operates. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Cultural Excellence provides a quality management framework for assessing and advancing an organization’s...

With this issue, Pharmaceutical Engineering^® launches a new feature in P+E: profiles of Communities of Practice (CoP) leaders. These leaders are central to the success of ISPE’s CoPs, which spearhead the generation of ISPE’s gold standard content, including Good Practice Guides, Pharmaceutical Engineering articles, conference presentations, and training programs.

With this issue, Pharmaceutical Engineering^® launches a new feature in P+E: profiles of Communities of Practice (CoP) leaders. These leaders are central to the success of ISPE’s CoPs, which spearhead the generation of ISPE’s gold standard content, including Good Practice Guides, Pharmaceutical Engineering articles, conference presentations, and training programs.

When nominating Martin (Marty) Lipa, Executive Director, Knowledge Management, Merck & Co. Inc., for the 2022 Max Seales Yonker Member of the Year Award, Anne Greene, Professor, Technological University Dublin, said, “Arguably the last year has been pivotal for the practice of knowledge management (KM) in the pharmaceutical industry based on new knowledge management frameworks and guidance...

ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Process Performance and Product Quality Monitoring System (PPPQMS) focuses on the key aspects of maintaining and establishing an effective PPPQMS. An effective PPPQMS is crucial to establishing and maintaining a state of control. It enables continual improvement and is key to proactively identifying the need for product quality and...

The Commissioning and Qualification (C&Q) CoP was one of the first Communities of Practices to be established at ISPE. One of its founding members, Steve Wisniewski, Principal Consultant, CAI, said the Communities of Practice was formed in 2004 to identify and promote more efficient approaches that resulted in pharmaceutical facilities being fit for their intended purpose.

The ninth ISPE Europe Annual Conference was the first in-person conference after a break of over two years due to the pandemic. For travel-related reasons, some attendees participated remotely. With 450 participants on-site and nearly 490 total attendees, the usual atmosphere of an

The 2022–2023 ISPE International Board took their places and the gavel passed to a new Chair during the 2022 ISPE Membership Meeting and Awards Lunch on 1 November during the 2022 ISPE Annual Meeting & Expo...

For nearly a century, production of water for injection (WFI) was universally accepted to be distillation-based. As emphasis on costs and environmental concerns has grown, pharmacopeias around the world have focused on the quality attributes of WFI to allow for consideration of other production technologies.

When the ISPE Baseline Guide Vol. 5, Commissioning & Qualification, 2 ed. was published in 2019, most of the attention was focused on the incorporation of quality risk...

Combination Products is one of ISPE’s newest Communities of Practice (CoPs). It started as a Special Interest Group to help people in the industry collaborate and learn from each other.

More than 400 attendees learned about the latest developments in biopharmaceuticals, cell and gene therapy, and ATMPs at the 2022 ISPE Biotechnology Conference, held 28–30 June in Boston, Massachusetts.

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.

Four teams of Emerging Leaders (ELs) represented one of four different company manufacturer types in the Emerging Leader Hackathon at the ISPE 2022 Europe Conference. This article provides some participants’ views of...

The Europe Hackathon for students and recent graduates was held 23–24 April as part of the activities during the 2022 ISPE Europe Annual Conference. This article provides an overview of the event and how it...

The members of the Sterile Products Processing (SPP) Community of Practice (CoP) Steering Committee are as diverse and varied as the topics they discuss. The Community of Practice is comprised of professionals from around...

Effective and timely management of change throughout the product life cycle enables quality improvement and is critical to patient safety, supply reliability, and operational effectiveness and efficiency. The ISPE Advancing Pharmaceutical Quality (APQ) Guide: Change Management System provides a quality management framework for assessing and advancing change management (CM) system maturity...

Eleanor Small, the 2021 recipient of the ISPE Max Seales Yonker Member of the Year award, uses her creativity and adaptability to discover new solutions in her work and to help ISPE succeed. She received the honor at the

ISPE has more than 17 global Communities of Practice (CoPs) where members can connect with each other. Professional Communities of Practices for

Released in November 2021, the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs)–Autologous Cell Therapy focuses on manufacturing facility development and design for autologous cell therapies for...

The lack of diversity in the pharmaceutical engineering industry is widely recognized. Less well understood is why change is so hard to achieve. From my years of work in this space, and through observation of ongoing efforts to embrace diversity in all forms, I have developed a hypothesis: Progress is stifled because we as a society wrongly believe diversity and inclusion efforts are...

The ISPE Annual Meeting & Expo is our signature event, uniting the pharmaceutical industry’s best and brightest to share their expertise, showcase their brands, and network. The 2021 ISPE Annual Meeting ...

Eamon Judge, the 2020 recipient of the Max Seales Yonker Member of the Year award, exemplifies the values behind the award: service to the industry and inspiring ISPE members to volunteer.

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 particular in the ISPE Baseline Guide: Commissioning & Qualification (Second Edition). The...

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.

The traditional passing of the gavel took place in person at the 2021 ISPE Annual Meeting & Expo on 2 November. The

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.

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.

The ISPE Foundation Diversity Internship Program has received strong response from applicants and has launched a new partnership.

The pharmaceutical industry in Spain and Portugal is growing, and the ISPE Iberia Affiliate—which has merged the Spain and Portugal Affiliates to take advantage of synergies between the two Affiliates—is working to train and support this expanding market.

Maintenance can impact both the quality of products and the compliance of pharmaceutical processes, and maintenance programs have long been recognized as critical to the success of the operations they support.

ISPE Emerging Leaders (ELs) held the first fully virtual International Hackathon in February. Fifty-one participants from over 22 countries encountered real-life challenges with working remotely and across time zones. Innovation...

The ISPE Aseptic Conference will celebrate its 30th year with the virtual conference on 15–17 March. The conference has been setting the pace for the evolution of sterile manufacturing processes and technologies in...

Equipment reliability helps reduce and manage the risk of failures in equipment, providing focus on availability, fitness for purpose, and cost. Reliable equipment improves the likelihood of achieving reliable manufacturing operations, which improves the supply of critical therapies to patients worldwide.

The 2020–2021 ISPE International Board of Directors began their term at the Member Meeting on 5 November during the

Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation, operation, and retirement of computerized systems supporting that business process.

To continue meeting the professional needs of ISPE members and with the global increase of virtual events due to COVID, ISPE has expanded its webinar offerings on topics important to ISPE members and industry sponsors.

The ISPE D/A/CH affiliate Is a Leader in Many Respects, from Its Ever-Increasing Size to the Invaluable Engagement of Its Members, Who Contribute to Ispe’s Growth around the World. Grouping Together Europe’s German-Speaking Countries—Germany (D), Austria (a), and Switzerland (Ch)—It Is Currently the Second Largest Ispe...

In honor of the 40th birthday of ISPE and Pharmaceutical Engineering®, we looked back to 2010 to see what technology-focused articles were published in the magazine. Here are just a few:

In March 2020, the ISPE Eurasian Economic Union (EAEU) Affiliate was officially established. This event was a significant step along the journey to integrate members from Eurasian Economic Union nations into the international pharmaceutical community, as well as another sign of progress in the development of a harmonized scientific,...

ISPE has published a new Good Practice Guide: Critical Utilities GMP Compliance—How to Be Compliant and Ready to Prove It. Written and reviewed by...

ISPE has a new special interest group (SIG) to work on IT cybersecurity. The Special Interest Group was formed under GAMP®. A conversation with Jason Young of Silver Bullet Security, who heads the new group, provides details about the Special Interest Group.

Pharmaceutical Engineering® has launched another new section on the Pharmaceutical Engineering Online site: Online Exclusives. Pharmaceutical Engineering Online Exclusives are articles published exclusively on the Pharmaceutical Engineering website. This new feature expands the...

As one of the larger and older ISPE Chapters, the ISPE Delaware Valley Chapter (DVC) is admired by other Chapters and Affiliates around the world.

The 2019 ISPE Max Seales Yonker Member of the Year Award was presented to Charlie Wakeham, a data integrity and compliance specialist based in Sydney, Australia, who has played an instrumental role in the development of GAMP®.

Before traveling to the 2019 ISPE Annual Meeting & Expo in Las Vegas, the ISPE Japan Affiliate held its annual phar-maceutical plant tour over five days (21–25 October), visiting two plants in Los...

The 2019 ISPE Europe Pharma 4.0™ Conference held in Manchester, UK, on 20–21 November 2019 was attended by 300 participants, all of whom contributed to the growing momentum for

Since its inception at the ISPE 2016 Annual Meeting & Expo, Women in Pharma® (WIP) has been rapidly growing. In the US and Europe, the society has held numerous Women in Pharma® events at local Affiliates, Chapters, and...

ISPE’s online site for Pharmaceutical Engineering was launched a little over one year ago, in November 2018. Here are some statistics about the site’s success during its first year.

Eric J. Staib

Head of Quality

Validated Cloud

ISPE’s newest Special Interest Group (SIG) will work on the emerging areas of artificial intelligence (AI) and machine learning (ML). The Artificial...

ISPE will introduce a new platform this fall for online Communities of Practice (CoPs) that will make the Communities of Practices more useful and user-friendly. Participating in a Communities of Practice by posting a...

The second day of the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston, 18–20 June, kicked off with the Women in Pharma® Balance for Better in Biopharmaceutical Manufacturing...

ISPE launched its complimentary Pharma Best Practices Webinar Series in April. The debut was outstanding, drawing more than 850 registrants and over 500 real-time participants representing 62 countries...

Delaware Valley Chapter Executive Vice President Eleanor Small, 34, is a woman with a passion for science and technology. Although still early in her career, she has already accomplished a lot, including being awarded the prestigious Delaware Valley Young Engineer of the Year award for 2019.

Young Professional Brita Salzmann, a Process Engineer with CRB and member of the ISPE Greater Los Angeles Chapter, loves the challenge of backpacking. She continues to add to her hiking resume, which includes treks across segments of the John Muir Trail in the Sierra Nevada Mountains of California, 14,000-foot-high peaks in Colorado, and national parks throughout the West. For Salzmann, the...

More than 200 attendees from manufacturers and key suppliers attended ISPE’s first European conference on aseptic manufacturing in the old capital of the Austro-Hungarian monarchy, Vienna. Austria is a hot spot for biopharmaceutical manufacturing with a number of global manufacturers or subsidiaries of major pharmaceutical companies. The

Record-setting 1,000 participants from 25 countries

Enhanced and accelerated regulatory pathways for “Breakthrough Therapies (United States) and “PRIME” medicines (European Union) have been introduced to provide faster access to exciting new therapies developed to treat unmet medical needs.1

• 1US Food and Drug Administration. Guidance for Industry. “Expedited Programs for Serious Conditions— Drugs and Biologics.” May 2014.

This year, ISPE Young Professionals held over 60 events in 15 countries, drawing more than 2,000 attendees—an amazing testament to the growth of the YP community. This Special Section details the success of these global activities and the IYPC’s exciting work over the past year.

Welcome to ISPE Briefs, a new column about happenings at ISPE—chapters and affiliates, conferences, and more.

Patient-Focused Harmonization Efforts in the Spotlight

Highlights from the stories of the five Category Winners and two Honorable Mentions of this year's Facilities of the Year Awards (FOYA) showcase pharmaceutical industry achievements.

This year's ISPE Annual Meeting & Expo will be held from 4 to 7 November in Philadelphia, Pennsylvania. The theme is "Vision to Reality: Delivering Next-Generation Therapies." The first keynote presentation, by Lars Fruergaard Jørgensen, President and CEO, Novo Nordisk A/S and Honorary Conference Chair, will address leadership in diabetes management and groundbreaking manufacturing...

Gain complimentary access to select ISPE Good Practice Guides through the new portal. Members appreciate the practical knowledge and real-world examples built into our Good Practice Guides, so we made them available for free on the Portal.

My road to becoming an ISPE chapter president started by joining a student chapter.

Chapter President Nicki Lange is cultivating an enthusiastic membership and building a professional community. 

ISPE's 2018 Facilities of the Future Conference highlighted emerging technologies that are driving change in pharmaceutical manufacturing. Topics included virtual reality, robotics, artificial learning, machine learning, and 3D printing. Education sessions were divided into Industry 4.0 and continuous manufacturing (CM) tracks.
 

Home to more than 51 million people, South Korea is one of the "Four Asian Tigers," along with Hong Kong, Singapore, and Taiwan. These countries experienced rapid expansion and high growth rates beginning in the 1960s, developing into highly advanced economies. South Korea's pharmaceutical industry is the third largest in Asia and the 13th largest in the world, with annual sales that are...

ISPE's revised IT Infrastructure Control and Compliance Guide provides comprehensive guidance on regulatory expectations for both traditional and cloud-based IT platforms. Have we done enough?

Special interest groups (SIGs) have been an important part of ISPE for many years. SIGs are formed around a specific area of interest, policy, or technology in which members have identified a common challenge. These "microcommunities" foster interaction among a variety of technical domains and often result in creative responses to industry change. SIGs must align with a community of...

In March 2017, ISPE submitted an extensive and detailed response1 to the 2016 US Food and Drug Administration (FDA) draft guidance "Submission of Quality Metrics Data,"2

• 1International Society for Pharmaceutical Engineering. Response to FDA Docket Number FDA-2015-D-2537. 27 March 2017. https://ispe.org
• 2US Food and Drug...

I'm setting a New Year's resolution to find a new position in 2018. Any advice on how to get started?

New RSC provides strategic direction and support

They say that ongoing growth is the key to a fulfilling career. If that holds true, young professional Lise Heyninck of Belgium has the mindset and drive to build a long and successful career in the pharmaceutical industry.

Attendees Tackle Trends, Big Issues

ISPE advisor John Berridge shares highlights from an EMA workshop on HBELs 

Hi David: I've landed a great co-op job that will start soon. Do you have any tips on how to maximize this opportunity?

ISPE's new online course on implementing a Quality Manufacturing program considers FDA 2016 draft guidance

Hi David, I am trying to make a career change. I want to move into a different area of engineering, and I am not having any luck. How can I be more effective?

ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)

There is still a lot of uncertainty on how to effectively structure a corporate data integrity program. It starts with the definition of the scope and often it ends with parallel work between departments who are owners of different systems along the value chain.

Delivering On Our Promise To Patients San Francisco, California 4–8 December 2016

Reinventing Commercial Biomanufacturing Frankfurt, Germany 24–25 October 2016

Hi Dave: I plan to attend a job fair soon, and would like to know if you have any tips on how to navigate it successfully.