The International Society for Pharmaceutical Engineering (ISPE) is a global not-for-profit association of pharmaceutical manufacturing professionals. ISPE is the Society of choice for nearly 23,000 pharmaceutical professionals in 80 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. To that end, the Society provides a wide range of Member-driven educational programs and resources to pharmaceutical industry practitioners worldwide.

The Society has collaborated on a variety of global projects with the FDA, as well as international regulatory agencies such as the Japanese Ministry of Health, Labor, and Welfare (MHLW) and the Medicines and Healthcare Products Regulatory Agency (MHRA). ISPE and FDA collaborations include the SUPAC equipment addendum listing for which both the Agency and ISPE were awarded the Hammer Award by former Vice President Al Gore’s office; the production of the ISPE Baseline® Pharmaceutical Engineering Guide Series; and a series of global forums that provided instruction and interpretation of the FDA’s guidance on process analytical technology (PAT).

ISPE’s extensive library of technical guides, developed in cooperation with global regulatory agencies, is in use by industry as well as regulators in many countries. The Baseline® Pharmaceutical Engineering Guide Series is considered an indispensable resource for designing, constructing, commissioning, and validating both new and renovated manufacturing facilities. Each Baseline® Guide is developed in partnership with the FDA, and offers practical solutions to the complex, dynamic challenges facing facility designers today.

Another prominent ISPE program is the Good Automated Manufacturing Practice (GAMP®) Forum, a technical sub-committee whose mission is to promote understanding of the regulation and use of automated systems within healthcare industries. The GAMP® Forum’s cornerstone publication is the GAMP® Guide for Validation of Automated Systems in Pharmaceutical Manufacture (GAMP 4), which provides a basic framework for validation and addresses considerations unique to particular classes of systems.

In addition, the Society conducts a year-round schedule of conferences focusing on current industry trends, and training courses that provide in-depth learning on a variety of topics for good manufacturing practice. ISPE’s Annual Meeting has become one of the industry’s most recognized events, drawing professionals and regulators, Members and nonmembers from around the world for a week-long schedule of educational programming and networking.

Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida; a European office in Brussels, Belgium; an Asia Pacific office in Singapore; and Affiliates and Chapters in 20 countries around the world. ISPE Members receive a variety of benefits including discounts on ISPE publications, conferences, and training; subscriptions to Pharmaceutical Engineering magazine and ISPEAK newsletter, access to Members-only content on the ISPE Web site, and membership in their local Affiliates or Chapters.

Visit www.ispe.org for additional Society news and membership information. Baseline® and GAMP® are registered trademarks of ISPE.