International Society for Pharmaceutical Engineering (ISPE)

ISPE Good Practice Guide: Validation 4.0

The Validation 4.0 Guide provides a comprehensive approach to ensuring product quality and patient safety throughout a pharmaceutical product's lifecycle.

Pharma’s Digital Transformation

Industry experts Michelangelo Canzoneri, Josef Trapl, Wolfgang Winter, Christian Woelbeling, and Thomas Zimmer – all members of ISPE’s Pharma 4.0 guide core team – explain the transformational challenges and critical success factors of the digital Pharma 4.0 journey.

503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies

A recently released guidance document, ISPE Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies, summarizes and contextualizes key information from US governmental bodies relevant to 503A pharmacies.

Takeda is Overall Winner of ISPE’s 2022 Facility of the Year Awards

The International Society for Pharmaceutical Engineering (ISPE) has announced Takeda Pharmaceuticals International as the 2022 Facility of the Year Awards (FOYA) Overall Winner.

AI Maturity Model for GxP Application

Artificial intelligence (AI) has become one of the supporting pillars for digitalization in many areas of the business world. The pharmaceutical industry and its GxP-regulated areas also want to use AI in a beneficial way, but only a small fraction of companies follows a systematic approach for the digitalization of their operations and validation. However, the assurance of integrity and quality of outputs via computerized system validation is essential for applications in GxP environments.

Shaping the Future of the Pharma Industry

The International Society for Pharmaceutical Engineering (ISPE) announced the 2022 Facility of the Year Awards (FOYA) Category Winners – including an Honorable Mention for Iovance Biotherapeutics, to be the first company in the world to commercially produce a personalized therapy for solid tumors.

Janssen Sciences Ireland is Overall Winner of ISPE’s 2021 Facility of the Year Awards

The International Society for Pharmaceutical Engineering (ISPE) has announced Janssen Sciences Ireland as the 2021 Facility of the Year Awards (FOYA) Overall Winner.

The Transition to Digitalization in the Pharmaceutical Industry

ISPE and its members are developing the roadmap to introduce Industry 4.0, also called the Smart Factory, at the pharmaceutical industry as Pharma 4.0 – an operating model that is interconnected, meaning that the digital tools allow for a fully connected network to enable direct communication between all levels in an organization.

A Roadmap for Pharma 4.0

Industry experts Josef Trapl, Wolfgang Winter, Christian Woelbeling, and Thomas Zimmer – all members of ISPE’s Pharma 4.0 group – talk about the idea behind ISPE’s Pharma 4.0 initiative and the challenges on the way to realize the digital transformation of the pharmaceutical industry.

Innovation and Creativity in the Pharmaceutical Industry

The International Society for Pharmaceutical Engineering (ISPE) announced the 2021 Facility of the Year Awards (FOYA) Category Winners—including two winners of Special Recognition Awards for Operational Agility: Covid-19 Impact.

Sanofi is Overall Winner of ISPE’s 2020 Facility of the Year Awards

The International Society for Pharmaceutical Engineering (ISPE) has announced Sanofi as the 2020 Facility of the Year Awards (FOYA) Overall Winner.

ISPE Elects Thomas B. Hartman as New CEO and President

Technology and Innovation in the Pharmaceutical Industry

ISPE Appoints Jean-François Duliere as European Regulatory Advisor

ISPE Appoints Tim Howard as Acting CEO and President

Innovation in Pharma Manufacturing

Managing Highly Challenging GMP Processes

Industry 4.0 and the Pharmaceutical Industry

Facilities of the Future

ISPE Recognizes Leaders in Drug Shortage Prevention

Where Cleanliness Becomes a Challenge

2015 Facility of the Year Awards Category Winners

Pfizer Ireland is Overall Winner of ISPE’s 2014 Facility of the Year Award

Conquering A Global Problem

Rentschler Facility Wins ‘Facility of the Year Award’ 2012 in Equipment Innovation

Pharmaceutical Technology - The new manufacturing facility of German biotech company Rentschler has won the 2012 Facility of the Year Award (FOYA) in the category "Equipment Innovation" for its flexible, multi-product manufacturing facility designed to minimize manufacturing costs and product cycle times.