Points to Consider for Knowledge Management Acceleration

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology Quality and Regulatory Sourcebook March 2023, Volume 2023 eBook , Issue 2
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.

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About the author

Cliff Campbell is senior consultant at KPC.

Article details

Pharmaceutical Technology
eBook: Quality and Regulatory Sourcebook
March 2023
Pages: 30–36

Citation

When referring to this article, please cite it as Campbell, C. Points to Consider for Knowledge Management Acceleration. Pharmaceutical Technology Quality and Regulatory Sourcebook eBook. March 2023.