The roots for the establishment of the ISPE Netherlands Affiliate of ISPE go back to the very first ISPE European congress as organized in Brussels in 1988. Quite a few people from the Netherlands attended that congress and were caught by the ISPE-spirit and ambitions.
The roots for the establishment of the ISPE Netherlands Affiliate of ISPE go back to the very first ISPE European congress as organized in Brussels in 1988. Quite a few people from the Netherlands attended that congress and were caught by the ISPE-spirit and ambitions.
We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the...
It’s hard to imagine life without instantaneous weather and time; however, some readers of this blog may know when weather, some years ago, was a mystery, and accurate time...
Register now for the 2023 ISPE Aseptic Conference, the #1 event for aseptic and sterile manufacturing professionals that has been setting the pace for over 30 years. Join us in North Bethesda, MD from 6–7 March 2023 to...
This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems...
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management)...
This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm...
Register now for the 2023 ISPE Aseptic Conference, the #1 event for aseptic and sterile manufacturing professionals that has been setting the pace for over 30 years. Join us in North Bethesda, MD from 6–7 March 2023 to...
Register now for the 2023 ISPE Facilities of the Future Conference, a one-of-a-kind event exploring advancements in technologies and what pharmaceutical manufacturing facilities will look like in the future. Join us 31...
Responding to unprecedented challenges from the pandemic, our industry has witnessed revolutionary ideas and newly established best practices that emerged and transformed the landscape of drug development and...
Good Practice Guide: Containment for Potent Compounds
Published
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)
Published
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.
This article explores life-cycle activities for machine learning (ML) within regulated life sciences. It positions and contextualizes the life cycle and management of the machine learning subsystem or components within a wider system life cycle...