A knowledge management standard or guideline is a good thing, but it is even better if it fully appreciates what knowledge management really is.
This guideline applies to the quality systems supporting the development and manufacture of pharmaceutical drug substances (i.e., API) and drug products, including biotechnology and biological products, throughout the product lifecycle.
One excellent element of this guideline is the inclusion of KM as part of the quality system, as follows:
1.6.1 Knowledge Management. 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, analysing, 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.The text above already contains a warning of potential confusion (did you spot it?) and this confusion is confirmed in the glossary to the document, as follows:
Knowledge Management: Systematic approach to acquiring, analysing, storing, and disseminating information related to products, manufacturing processes and components.
So - great - the document acknowledges that knowledge is a crucial element in delivering quality. Not so great - it defines KM as the management of information - a definition of Information Management, not of Knowledge Management.
Overall I believe the inclusion of KM in this document is a positive step for the Pharma industry, and now just needs to take the next step and recognise that KM is not about the management of information, but about the management of knowledge, both documented and tacit.
Not all information is knowledge, and not all knowledge is documented in information form. Confusion between the management of information and the management of knowledge will, I hope, be resolved in future issues of this guideline, and will provide the next step forward for the use of KM in the Pharma industry.