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46 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com janews094 - stock.adobe.com A published paper, titled "Quality Quartets in Risk-Based Qualification" (1), provid- ed a review of the International Society for Pharmaceutical Engineering's (ISPE's) Baseline Guide of 2019 on Commissioning & Qualifi- cation (C&Q) (2). That paper introduced a concept called "Quality Quartets" as a practical means of making use of four key concepts in the Baseline Guide: critical aspects (CAs) and critical design ele- ments (CDEs), which were newly introduced in the 2019 Baseline Guide, and the already well established critical quality attribute (CQA) and critical process parameters (CPP) concepts. A Qua lit y Qua r tet is essent ia l ly a documented expression of t he k nowledge t hat a company has about the relationship between CAs and CDEs and t he a ssociated CPPs a nd CQA s. It ca n be con sid- ered a k nowledge m a n agement out put , ser v i ng a s a prac t ica l mea n s of f ac i l it at i ng sc ience a nd r isk-ba sed com m ission i ng a nd qua l i f icat ion. I n addition, the Qua lit y Quar tet concept represents a simple and concise means of capturing and com- mun icat i ng produc t a nd process k nowledge a nd understanding. T h i s pap e r de s c r i b e s t he b e ne f it s of m a k i n g use of this Qualit y Quar tet concept as a means of Quality Quartets in Risk-Based Qualification: ICH Q9(R1) Considerations Kevin O'Donnell is Market Compliance Manager at Ireland's Health Products Regulatory Authority. Cliff Campbell is senior consultant, retired. Editor's Note: This article was peer reviewed by a member of Pharmaceutical Technology®'s Editorial Advisory Board and was previously published in the August 2023 issue. Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.