Cultural Excellence is the expressed and implied ways in which an organization operates. Excellence in organizational 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,...
Knowledge management (KM) has been a recognized discipline for over 20 years in other industries, although within the biopharmaceutical industry, its discussion and formal implementation have been slow to gain momentum. The topic gained regulatory significance in 2008 when the ICH guidance document Pharmaceutical Quality System: Q10 included knowledge management as a key enabler of a...
The 2018 ISPE Quality Manufacturing Conference, held 4–6 June 2018 in Arlington, Virginia, included a well-attended session entitled “Data Integrity—Beyond the Lab,” which reaffirmed continued focus...
Notes from the recent meeting of the European GMP/GDP Inspectors Working Group (IWG)
ISPE Quality Culture Team members share key concepts represented in the Six Dimensions of Cultural Excellence framework.
