Investigation Effectiveness Drives Human Performance Excellence
Are investigations supporting or hindering performance excellence?
Every biopharm company conducts investigations for undesirable outcomes related to safety, quality, and reliability of product and processes. The question is to what degree do these investigations support or hinder performance excellence?
A sub-team that was formed as part of the BioPhorum Operations Group (BPOG) human performance workstream sought to answer this question. The findings suggest that biopharm is behind other industries with respect to investigation best practices.
This article provides a pathway for the industry to improve its investigations, and in so doing, improve overall organizational learning and performance.
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Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
