ISO 9001:2015 vs ICH Q10 - A Comparison

Carsten Aaberg; Heribert Dahmen; Cledwyn Davies; Pia Lise Sandau; Raman Srinivasan

doi:10.5731/pdajpst.2020.011692

Abstract

Do changes to ISO 9001 from the 2008 version to the 2015 version warrant revision of ICH Q10? Or does ICH Q10 still meet the ISO 9001 principles? In 2008, the International Conference on Harmonization (ICH) issued guideline ICH Q10, describing a model for a Pharmaceutical Quality System (PQS) that can be implemented throughout the different stages of a product life cycle. Explicitly, the guideline was not intended to create any new expectations beyond the existing regulatory requirements. ICH Q10 was founded on principles established by the International Organization for Standardization (ISO) describing a model for the structure of a Quality Management System (QMS). From 1987 these principles had been codified in the ISO 9000 series of quality standards, for example, as revised in ISO 9001: 2008. ICH Q10 also incorporated applicable Good Manufacturing Practice (GMP) regulations and complemented the existing ICH Q8 ″Pharmaceutical Development″ and ICH Q9 ″Quality Risk Management″ guidelines. ICH Q10 represents a harmonized model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. In 2015, ISO published ISO 9001:2015, a significant revision to the ISO 9001 Quality Management System standard. This 2015 version contained extensive changes and a new structure. This revision to ISO 9001 raises the question of whether ICH Q10 should be reviewed and potentially revised, and whether ICH Q10 continues to meet the ISO 9000 principles. This article assesses whether the changes to the ISO 9001:2015 standard could make a revision of the ICH Q10 guideline necessary and whether ICH Q10 still represents a current model of a pharmaceutical quality management system.

Received May 11, 2020.
Accepted August 24, 2020.

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