SES

This presentation explores the practical considerations for designing pharmaceutical facilities in line with Pharma 4.0 principles. Early input in the design stages is crucial for the successful implementation of smart manufacturing solutions, as demonstrated by AstraZeneca's new API Clinical and Commercial Manufacturing Facility in Dublin. This state-of-the-art, paperless, digital smart factory integrates enterprise IT systems with operational technologies to enhance efficiency, quality, and innovation.

The complexity of global manufacturing is driven by networks of internal and external manufacturing as well as network effects due to product classes. Takeda has created a small, cross-functional team of investigators that engage in global investigations resulting from supplier disruption notifications, that are network in scale, have significant patient impact, or are directly affecting regulatory activity.

Discover how three essential ISPE guides work together to create a comprehensive validation strategy for the modern pharmaceutical industry. This session explores the complementary strengths of the ISPE GAMP 5 2nd Edition, ISPE Digital Validation Guide, and ISPE AI Guide, showing how each addresses distinct but interconnected aspects of tPharma 4.0. The GAMP 5 2nd Edition provides the foundational risk-based approach and proven methodologies that remain the backbone of pharmaceutical validation.

In the complex, multi-step processes of parenteral manufacturing, the unique identifiers (UIDs) that could create the granular upstream visibility needed to ensure timely batch release and detailed root-cause analysis are hard to come by. Digital unique identifiers such as shift register IDs lose track of the unit across machine or section boundaries. Physical container markings such as RFID or 2D codes are introduced too late in the process – or not at all.

Join us for ISPE 16th Annual ISPE 5K Run/Walk held during the ISPE Annual Meeting & Expo. Your participation in this year’s 5K event will again support ISPE Foundation’s mission fueling global health equity by fostering access to knowledge and nurturing diverse talent. Additional registration and a donation fee of $100 is required to participate. Registrants must collect their bibs and t-shirts at the Information Desk onsite.

A Case Study, describing how ISPE Guidance was utilized to help a leading Life Sciences Organization Implement and Validate. The presentation will explain a real life example of utilizing guidance to get from the base steps of Connectivity to the enhanced interconnected plant. It will explain the steps taken by the organization, including initial risk assessment and the different interdisciplinary teams working together and phases required to realize the project and commission the new plant.

This session will build upon the keynote presented in December 2024 and share new work carried out since then by the Life Sciences Advisory Board representatives. Many organizations have made significant investments in new facilities and have significant challenges ahead in hiring/skilling suitable people to fill these roles. Skilling, up-skilling and workforce development topics are a pre-competitive space for leading Life Sciences organizations.