ISPE’s Post

Having a universal and uniform Common Technical Document (CTD) for all markets, major and emerging, is an aspiration of all pharmaceutical companies. As markets become more familiar with the CTD, especially the quality portion, some drug regulatory agencies are requesting more regional/local documents and customization to CTD documents in accordance with their local interpretation and understanding of the ICH M4Q(R1) guideline, “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality.” It may be that the agency wants to find specific information quickly and easily, such as the manufacturer of the master and/or working cell bank. Learn more: https://hubs.la/Q02DrkGR0 #ISPE #CTD #pharma #pharmaceuticalengineering #pharmaceuticalmanufacturing

Join us in Orlando for the 2024 ISPE International Emerging Leader Hackathon sponsored by Genentech. This immersive event is taking place before the 2024 ISPE Annual Meeting & Expo. We encourage students and recent graduate members to participate in this event, where participants will break out into smaller teams and work strategically to create a solution for the provided problem statement. Register now: https://hubs.la/Q02FWw4t0 #ISPE #ISPEAM24 #hackathon #ISPEhackathon #pharma

This guide provides an overview of FDA regulations and guidance necessary for conducting safe compounding to help pharmacies understand the requirements of FD&C Act Section 503A. In addition, the ISPE Guide outlines the authority of State Boards of Pharmacy and their coordination of oversight with the FDA. Get the guide: https://hubs.la/Q02FPnhT0 #ISPE #503acompounding #compounding

Meet the 2024 FOYA Category Winner for social Impact - 中外製薬工業 / Chugai Pharma Manufacturing Co., Ltd. Chugai Pharma has built a 40,000-square foot facility. specifically designed for the manufacture of early-stage investigational medicinal products. It consists of a four-floor production building with office space and material storage on the first floor, manufacturing areas on the second and third floors, and utilities on the fourth floor and roof. The culture room houses 50, 500, and 2000 liters of single-use bioreactors and has two 2000 liters of production-scale single-use bioreactors. This project is without a doubt a model for sustainable design. By employing innovative and interconnected solutions, Chugai has been able to deliver in UK4 a greenhouse-gas-free manufacturing facility ready to fulfill their mission of manufacturing the potential medicines of the future. This is why Chugai Pharma Manufacturing Co., Ltd has been named the 2024 ISPE Facility of the Year Award (FOYA) Category Winner for Social Impact. Learn more: https://hubs.la/Q02FPk9B0 #ISPE #FOYA #Chugai #pharma #sustainability

Digital Transformation, ATMPs, and AI are just a few of the topics that will be covered at this signature ISPE conference. This event is not just an opportunity to learn but also to connect. From emerging talents to seasoned executives in drug manufacturing, supply chain, devices and equipment and services, and global regulatory agencies, attendees will get the chance to network, exchange insights, and preview the latest technologies and services in our expo hall. Register now: https://hubs.la/Q02FGwV_0 #ISPE #ISPEAM24 #AM24 #ISPEAnnualMeeting #atmp #ai #pharma #pharmaai #digitaltransformation

The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide: Advanced Therapy Medicinal Products – Recombinant AAV Comparability and Lifecyle Management were published earlier this year. These guides add to ISPE’s library of knowledge in the growing and ever-evolving advanced therapy medicinal products (ATMPs) field. Learn more about these two new guides: https://hubs.la/Q02FF8cj0 #ISPE #ATMPs #Allogenic #raav

Join us for an in-depth discussion on the ISPE Baseline® Guide: Pharma 4.0™. This guide contains tools and advice for companies in achieving their digitization and financial goals while maintaining/improving product quality and meeting regulatory requirements and expectations. In addition, this Guide outlines various starting points, prerequisites, governance structures, and strategies for achieving transformational success tailored to an organization’s size, risk tolerance, flexibility, and maturity level. Speakers include authors Teresa Minero, Michelangelo Canzoneri, Yvonne Duckworth, PE, Paige Kane, PhD, CPIP, Christian Wölbeling, Vinzenz Zauner, and Thomas Zimmer. Register for this complimentary webinar: https://hubs.la/Q02Fr4gh0 ISPE webinars can be accessed on-the-go via the free ISPE mobile app, by selecting the "Menu" option: https://hubs.la/Q02Fr2Sp0 #ISPE #pharma #pharmawebinar

Work with us to build a customized training program to meet your teams' specific needs. We leverage our global membership to find topic experts to create, and instruct, world-class training courses. We offer courses on topics like, Biotechnology, Commissioning and Qualification, GAMP, GMPs, Validation, and more. Keep up with industry innovations and regulations with ISPE Training. Build a custom training program for your team today: https://hubs.la/Q02Fr3XJ0 #ISPE #ISPETraining #PharmaTraining #BiotechTraining

Join speakers Timothy Hajj, Martina Marauli, and Kristel Rens as they discuss the content of the article of the same topic featured in ISPE PE magazine in the March / April 2024 edition. The speakers will cover the high-level content of the article, discussing some of the areas in more detail and will then give the opportunity for questions relating to the article to be addressed and discussed. Register now for this complimentary webinar: https://hubs.la/Q02Ff_h-0 Read more about the topic: https://hubs.la/Q02FfWYr0 #ISPE #ISPEWebinar #PharmaWebinar

Sterile drug production has always been a challenging task to perform in the pharmaceutical industry. There are many requirements to fulfill: to assure product quality, to protect the operator when potent compounds are present, to achieve high levels of efficiency,.…. And all of them must comply with the existing pharmaceutical regulations. In Europe, the main directives to follow are 2001/83/EC and 2017/1572. Annex I of these guidelines for CGMPs was modified in 2022 and it has agitated the sector as human intervention is explicitly not accepted at all under class A conditions. This article will analyse how to address these challenges in different scenarios. Read more in this sponsored article from Azbil Telstar: https://hubs.la/Q02Fh41g0 #ISPE #Telstar #pharma