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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.
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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.
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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...
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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
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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...
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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.
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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...
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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.
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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.
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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.
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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...
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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.
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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.
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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...
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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
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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.
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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.
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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...
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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.
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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.  
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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...
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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?
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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...
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In March 2017, ISPE submitted an extensive and detailed responseInternational Society for Pharmaceutical Engineering. Response to FDA Docket Number FDA-2015-D-2537. 27 March 2017. https://ispe.org to the 2016 US Food and Drug Administration (FDA) draft guidance "Submission of Quality Metrics Data,"US Food and Drug...
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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.
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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.