Quality Quartets in Risk-Based Qualification

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The Quality Quartet is a proposed technical mechanism to eliminate inconsistencies and deficiencies within and between the commissioning and qualification (C&Q) and process validation (PV) lifecycles. Quality Quartets are four-component objects comprising two process and two system parts, but itemized and managed as singularities. Using a combination of International Council for Harmonisation (ICH) and International Society of Pharmaceutical Engineering (ISPE) terminology, the process parts are critical quality attribute (CQA) and critical process parameter (CPP), and the related system parts are critical aspect (CA) and critical design element (CDE). When implemented, Quality Quartets clearly demonstrate 100% connectivity between C&Q and PV datasets. They also facilitate unambiguous communication between product development and facility delivery silos, and between manufacturers and regulators.

ISPE re-issued its C&Q Baseline Guide in 2019 to take account of the global regulatory expectation for patient-centric, risk-based design and delivery of manufacturing processes and systems. The guide now runs to more than 200 pages, including appendices (1).

This paper explains the essential aspects of the guide. The guide is summarized by annotating its underlying principles and recommended workflow. Several practical recommendations are included targeted at optimizing implementation of the guide. Advantages of grouping CQAs, CPPs, CAs, and CDEs into Quality Quartets are discussed.

About the author

Cliff Campbell is senior consultant at KPC.

Article details

Pharmaceutical Technology
Vol. 47, No. 5
May 2023
Page: 53-57

Citation

When referring to this article, please cite it as Campbell, C. Quality Quartets in Risk-Based Qualification. Pharmaceutical Technology 2023 47 (5).