Kevin O’Donnell is Market Compliance Manager at Ireland’s Health Products Regulatory Authority.

Kevin ODonnell 

risk management and risk assessment concept | Image Credit: janews094 - stock.adobe.com

 This article was peer reviewed by a member of 

®’s Editorial Advisory Board and was previously published in the August 2023 issue.

A published paper, titled “Quality Quartets in Risk-Based Qualification” (1), provided a review of the International Society for Pharmaceutical Engineering’s (ISPE’s) Baseline Guide of 2019 on Commissioning & Qualification (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 elements (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.

Quality Quartets in Risk-Based Qualification: ICH Q9(R1) Considerations

Regulating Innovation, Quality, and Risk eBook January 2024

A Quality Quartet is essentially a documented expression of the knowledge that a company has about the relationship between CAs and CDEs and the associated CPPs and CQAs. It can be considered a knowledge management output, serving as a practical means of facilitating science and risk-based commissioning and qualification. In addition, the Quality Quartet concept represents a simple and concise means of capturing and communicating product and process knowledge and understanding.

 Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk

Kevin O’Donnell is Market Compliance Manager at Ireland’s Health Products Regulatory Authority. Cliff Campbell is senior consultant, retired.

Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk

Articles

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.