Points to Consider for Knowledge Management Acceleration

Published on: 
BioPharm International, BioPharm International Quality and Regulatory Sourcebook 2023, Volume 2023 eBook, Issue 1
Pages: 30-36

Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.

Biopharma systems and processes are outlined in the introductory section of this monograph. A new knowledge management (KM) paradigm is then described, beginning with an analysis of United States and European Union regulatory requirements, and of prevailing commissioning and qualification (C&Q) and quality risk management (QRM) guidance from the International Society for Pharmaceutical Engineering (ISPE) and International Council for Harmonisation (ICH).

The KM paradigm is a response to the expectation that C&Q and QRM be integrated and accelerated, on urgent fast-track projects (the new normal) in particular. It is based on pattern recognition, and on the insight that process-related critical quality attributes (CQAs) and critical process parameters (CPPs), and plant-related critical aspects (CAs, or functions) and critical design elements (CDEs, or components), are best managed via a previously unrecognized fundamental object called quality quartet, comprising CQA:CPP:CA:CDE parts. Several well-established and universally accepted benchmarks are listed in support of the paradigm.


Read this article in BioPharm International’s March 2023 Quality and Regulatory Sourcebook eBook.

About the author

Cliff Campbell is senior consultant at KPC.

Article details

BioPharm International
eBook: Quality and Regulatory Sourcebook
March 2023
Pages: 30-36


When referring to this article, please cite it as Campbell, C. Points to Consider for Knowledge Management Acceleration. BioPharm International’s Quality and Regulatory Sourcebook eBook (March 2023).