Continued process verification (CPV) is an activity that provides ongoing verification of the performance of a manufacturing process. Guidance issued by the FDA in 2011 emphasized the importance of manufacturers engaging in CPV as an integral part of their process...
A critical part of establishing competence in human performance in the biopharmaceutical industry is creating a culture where leaders partner with workers to learn about what enables success and what creates challenges. This learning is most effectively done through...
This guide developed by the Human Performance (HuP) team has explains how biopharmaceutical operations can understand and measure performance in a more meaningful way to capture risks and enable sustainable learning and improvement, through what is known as the Family...
The foundational document Continued process verification (CPV): An industry position paper with an example plan published in 2014 describes how to implement CPV. This helped companies accelerate the implementation of CPV by 30% and decreased investigation times by up...
Errors are a part of life. In a pharmaceutical context, though, errors affect safety and quality and can lead to issues with supply. Direct financial impact from lost batches, investigations, and remediation activities—as well as compliance issues, higher inventory...
