Message from the Chair: Celebrating 45 Years of Innovation
For nearly half a century, ISPE has served as a resource for the industry. With a global footprint that includes 22,000 members representing 120 countries, we continue to provide guidance to address pressing challenges within the industry.
ISPE is growing. We now have 22 Communities of Practice (CoPs), with the recent additions of Artificial Intelligence (AI) and Sustainability CoPs. Our global presence is expanding as well, with 40 Affiliates and Chapters.
We are proud of our history and always want to engage with pharmaceutical engineers who have been with us from the start. As we look ahead to 2025, we also want to broaden our collective perspective to ensure we’re supporting all aspects of the pharmaceutical industry. We will advance our vision of shaping the future of the global pharmaceutical industry by providing solutions to complex challenges through manufacturing and supply chain innovation, member and workforce development, and technical, regulatory, and quality leadership.
In 2025, we will stay true to our mission: ISPE is the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing innovation, supply chain resilience, operational excellence, and regulatory insights to advance industry efforts to develop, manufacture, and reliably deliver quality medicines to patients. This en-tails a more expansive approach. It involves a heavy focus on engagement with regulators and those in quality assurance.
Focus On Innovation
The industry shows persistent promise and, at the same time, has complex challenges to address on the road ahead. These include manufacturing and supply chain inno-vation, member and workforce development, and technical, regulatory, and quality leadership.
We have made strides in providing GAMP-related guidance to the industry and will extend our commitment to do so in 2025. We are grateful to our dedicated “GAMPers” for their many years of service as dedicated volunteers and are happy to celebrate the 25th anniversary of GAMP Americas.
In 2024, we released the ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition). As we look ahead to 2025, we have already begun to pursue revisions of at least three ISPE GAMP Good Practice Guides to ensure they are as up to date as possible. We were also proud to announce our ISPE AI® initiative in the second half of 2024. We will endeavor to support companies and the industry in the responsible adoption of AI as more applications are identified and case studies are tested for this rapidly evolving technology. Additionally, ISPE was recognized with an APEX Award of Excellence in Writing for “ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma,” published in Pharmaceutical Engineering® in 2024. This marks the fifth consecutive year Pharmaceutical Engineering® has received an APEX Award.
In 2025, we look forward to releasing a highly anticipated ISPE GAMP® Good Practice Guide on AI. We will also advance our recently launched AI CoP. Our conference attendees will continue to benefit from educational sessions on AI. Our 2024 ISPE Annual Meeting & Expo included 16 presentations on AI. We’ll provide even more AI- and Pharma 4.0™ related content in 2025 at the upcoming 2025 ISPE Facilities of the Future Conference and 2025 ISPE Biotechnology Conference. In the second half of 2024, we launched three AI-focused webinars, all part of a six-part series titled, “AI/ML in Regulated (GxP) Life Sciences Sectors.”
Sustainability is another priority area for which ISPE is providing additional support to the industry. We launched a new Sustainability CoP in late 2024. We will continue to grow this CoP and plan to release an ISPE guide on sustainability in 2025. Additionally, we will accelerate our strides in Pharma 4.0™ to support the industry’s persistent pursuit of digital transformation as new technologies proliferate.
Recent ISPE Accomplishments
I’d like to take a moment to highlight an especially significant ISPE accomplishment that has positively impacted the industry: the release of the updated ISPE Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities (Third Edition) in late 2023. The first edition of this ISPE Baseline Guide was released in 2004. At that time, bio-pharmaceutical practitioners were aware of the wide variety of processes available, and with parallel improvements in analytical methods, they had evolved a better understanding of the cause-and-effect relationship between process variables and product quality. However, the technology was still advancing rapidly, and the industry was working hard to move forward. For example, single-use technology and segregation of open processes in isolators were not yet widely adopted technological advances in 2004. The industry still had a lot to learn, and companies had a lot to learn about adapting to new biopharma technology.
Fast-forward to 2023: The biotech industry has matured significantly, and the latest revision of this ISPE Baseline Guide has been updated substantially. I highly recommend investing in this valuable resource if you haven’t done so already. The ISPE guide team that wrote the 2023 edition has done a great job.
We anticipate a successful year ahead: celebrating our successes, honoring our commitment, and shaping the future of the pharmaceutical industry. We will continue to expand ISPE’s service to the industry by connecting pharmaceutical knowledge to help organizations deliver manufacturing innovation, supply chain resilience, operational excellence, and regulatory insights to support the development, manufacturing, and reliable delivery of quality medicines to patients. Thank you for your support. We look forward to sharing a successful year together.
