Quality Quartets in Risk-Based Qualification:

Published on: 
Pharmaceutical Technology, Regulating Innovation, Quality, and Risk, January 2024 eBook, Volume 2024 eBook, Issue 1
Pages: 46-51

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

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.

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.

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.


Read this article in the Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk eBook.

About the authors

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

Article details

Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk eBook
Issue 1
January 2024
Pages: 46-51