Quality and Regulatory Sourcebook eBook March 2023
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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).
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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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Cliff Campbell is senior consultant at KPC.
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).
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