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30 Pharmaceutical Technology ® Quality and Regulatory Sourcebook March eBook 2023 PharmTech.com RELIF - STOCK.ADOBE.COM B iopharma systems and processes are outlined in the introductory section of this mono- graph. A new knowledge management (KM) paradigm is then described, beginning with an analysis of United States and European Union regu- latory requirements, and of prevailing commissioning and qualification (C&Q) and quality risk management (QRM) guidance from the International Society for Phar- maceutical Engineering (ISPE) and International Coun- cil 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. The emergence of quality quartets is a logical conse- quence of the ISPE C&Q model, and a targeted response to the subjectivity, formality, and clarity shortcomings of the ICH Q9 original guideline on QRM, QRM, whose revision ICH Q9 (R1) was approved and finalized on Jan. 18, 2023 (1). The paradigm is risk-based, lifecycle-driven, and in alignment with the established stages of qualifi- cation, with CDEs tested at installation qualification (IQ), CAs at operational qualification (OQ), CPPs at process performance qualification (PPQ), and CQAs at process validation (PV); all four are being conducted in the con- text of the source quality quartet. Quality quartets are qualified in toto at design qualification (DQ), based on an enhanced interpretation of this activity. Points to Consider for Knowledge Management Acceleration Cliff Campbell is senior consultant at KPC. Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.