The new ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations involved a cross-functional team of industry experts and professionals from parenteral/injectable medicine manufacturing. The team included industry competitors who worked together to establish a common approach. They provided a balanced, industrywide perspective on...
In April 2024, ISPE published the ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good Practices for Pharmacies, adding to the growing body of knowledge ISPE is producing for the pharmaceutical compounding industry. Written by industry experts and reviewed by practitioners in the area, the guide provides an overview of relevant US Food and Drug Administration (FDA) regulations and...
Rod Freeman started his career in the pharma-ceutical industry as an analytical chemist.
Growing up on a farm, Allen Koester thought he would design farm equipment after earning his degree in mechanical engineering.
The ISPE International Company of the Year award recognizes outstanding leadership and support provided by a company, as reflected by significant active participation in the Society’s committees, Communities of Practice (CoPs), programs, and activities, as well as its support of employee participation in ISPE. The winner for 2023, Roche, was announced at the 2023 ISPE Annual Meeting & Expo...
One of the primary technical objectives of the ISPE Pharma 4.0™ Plug and Produce Working Group is to assist the Pharma 4.0™ digital transformation by enabling seamless integration and interoperability between all systems components and operational technology to advance the overall digital maturity toward predictive and adaptable operations.
