We lead and facilitate the development of next generation process technologies and innovative technical solutions. On matters of regulation, our focus is on those requirements that impact — or will impact — the licensing of facilities, manufacturing processes and operations, and the sustainability of the supply chain over the product lifecycle. ISPE provides a neutral environment where our individual Members and experts belonging to Regulatory Authorities can engage in open dialogue on issues that will ultimately benefit patients around the world.
Our Purpose: ISPE delivers technical and operational solutions to support our Members across the global pharmaceutical and biopharmaceutical industry in the manufacture of quality medicines for patients.
ISPE aims to offer increasing and unparalleled value for Members, companies and stakeholders globally and across all constituent parts of the industry. The result will be the continued improvement and transformation of the pharmaceutical manufacturing industry to better ensure the availability of quality medicines.
Our Guides are relied on globally by industry and regulators to define the industry standards for design, construction and operation of pharmaceutical manufacturing facilities. ISPE’s training, conferences and Knowledge Networks give professionals solutions for their needs and connect them with other professionals to share best practices. We know how to design, build, qualify, license, operate and maintain these complex facilities, including those that manufacture active pharmaceutical ingredients, finished dosage forms, delivery systems and packaging. Through ISPE's branded expertise in these areas we have deep technical knowledge that is applied in a practical manner.
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle.
ISPE is committed to the advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience.
ISPE was founded in 1980 by a handful of people who believed the pharmaceutical industry needed an organization that would deal with practical applications of science and technology for technical professionals. The much-needed forum provided by ISPE began with a Membership of engineers in North America. In time, ISPE Membership expanded beyond engineering to include a broad representation from pharmaceutical professionals.
All scientific and technical areas of the pharmaceutical manufacturing industry are represented among the ISPE Membership. Engineers, microbiologists, chemists, QA/QC, production, process development, pharmacists, regulatory and training personnel, academia, suppliers, and other professionals contribute their expertise to the industry through their participation in ISPE activities.
ISPE is led by an International Board of Directors. James A. Breen, Jr., PE is the Society's Chair for 2018 – 2019.
ISPE is supported by a global staff of association professionals and advisers under the leadership of President and CEO John Bournas.
ISPE provides support for the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF).