International Society for Pharmaceutical Engineering
Budget
€600 — €0
EP Access
0
accredited persons
Staff
12
3.55 FTE
EU Grants
None
Mission & Goals
The International Society for Pharmaceutical Engineering (ISPE) is a nonprofit association serving its members by connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients. ISPE's members are pharmaceutical professionals who use expert knowledge to create high-quality, cost-effective GMP solutions. All scientific and technical areas of the pharmaceutical manufacturing industry are represented among the ISPE Membership. The Society’s Guidance Documents are relied upon globally by industry for design, construction and operation of pharmaceutical manufacturing facilities. ISPE’s training, conferences and technical communities of practice provide professionals with solutions for their needs and connect them with other professionals to share best practices.
EU Legislative Interests
ISPE follows and responds to the publications of the EC, EMA, EDQM, National Competent Authorities, and PIC/S in areas related to pharmaceutical manufacturing such as: Advanced Therapies, Active Pharmaceutical Ingredients, Aseptic Processing, Drug Shortages, Data Integrity, GMPs, Medicinal Products, Digital Transformation, Sustainability, and Quality. ISPE has spoken on behalf of its membership and provided scientific insights at the invitation of the EMA Inspectors Working Party. Expert group members speak at ISPE conferences.
Communication Activities
ISPE’s professional activities include contributions to EMA groups such as the Inspectors’ Working Party, Quality Innovation Group, and the EMA initiative on Drug Shortages. ISPE maintains an active website, comments on draft scientific guidelines such as those published by the EMA, and publishes a wide range of best-practice guides for members. Additionally, ISPE offers training programmes for both industry and regulatory agencies.
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
ISPE participates in a group of associations coordinated by Efpia that acts as interested parties in communication with the EMA GMP/GDP-IWG. For 2025, the Interested Parties include the following: Active Pharmaceutical Ingredients Committee (APIC), Affordable Medicines Europe, AnimalhealthEurope, Association of the European Self-Care Industry (AESGP), European Association for Logistics and Transport in Healthcare (EALTH), European Compliance Academy, European QP Association (ECA/EQPA), European Federation of Pharmaceutical Industries and Associations (EFPIA), European Healthcare Distribution Association (GIRP), European Industrial Pharmacists Group (EIPG), International Pharmaceutical Excipients Certification (EXCiPACT), International Pharmaceutical Excipient Council (IPEC), International Plasma.
Organisation Members
Not applicable.
Commissioner Meetings
No recorded meetings with EU commissioners.