Since 2008 and the publication of ICH Q10, the importance of the role of knowledge management has been clearly Knowledge Image positioned as one of two key enablers necessary for the successful implementation of an …
Short piece which references an April 2009 FDA Guidance for Industry for Pharmaceutical Quality System(s) in which Knowledge Management is described as an “enabler” for the industry in implementing quality standards.
From the FDA guidance itself:
“Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components. Sources of knowledge include, but are not limited to, prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities.”
While the pharmaceutical industry has made significant gains in the area of Knowledge Management, there are still opportunities available to be taken from the need for “leadership” within the industry to “establish and maintain company-wide commitment to quality” and in leadership recognizing the importance of Knowledge Management.
Knowledge Management should and can play a key role in Quality Management.
See on blog.ispe.org