The EASE Training Center provides Hands-on opportunities to interact with facilities, equipment, and staff members in an industrial environment specifically built for training pharmaceutical industry workers. Visit EASE...
Taking place 8–10 May 2023 in Amsterdam, The Netherlands, the 2023 ISPE Europe Annual Conference will explore digital transformation and Pharma 4.0™, Annex 1, good engineering practice, supply chain resiliency and GAMP 5...
ISPE prides itself on providing our members the technical knowledge and networking resources necessary to make your mark on the industry and Shape the Future of Pharma™. Join today to take full advantage of the many...
Good Practice Guide: Containment for Potent Compounds
The ISPE Good Practice Guide: Containment for Potent Compounds covers all aspects of pharmaceutical containment including background to safe working levels and the mechanisms of exposure and how such exposure can be controlled. There are chapters on typically applied approaches used in containing exposure for commonly applied process systems across all elements of pharmaceutical development and manufacturing.
Cultural excellence is the expressed and implied ways in which an organization operates. Excellence in quality culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. Culture determines quality outcomes by affecting the organization’s ability to identify and act upon near-miss shortages, ensuring the integrity of its data, assuring transparent problem escalation, and striving for operational excellence.
APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
The Process Performance and Product Quality Monitoring System (PPPQMS) is a fundamental element of the PQS described in ICH Q10. An effective PPPQMS ensures a state of control is maintained and facilitates continual improvement. The ISPE APQ Guide: PPPQMS provides a quality management framework for assessing and advancing an organization’s PPPQMS.
Maintaining the principles and framework of the First Edition, GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of service providers, evolving approaches to software development, and the more widespread use of software tools and automation. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches.
North Carolina’s Research Triangle is the largest of its kind in the US. Thanks to years of effort from industry, pharmaceutical professionals, and education institutions, it is synonymous with pharmaceutical and biotechnology excellence.