The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the different goals and knowledge available for each stage.

ICH Q10 provides a harmonised model for a pharmaceutical quality system throughout the lifecycle of a product and is intended to be used together with regional GMP requirements.

This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry,...

This guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e. API) and drug products, including biotechnology and biological products, …

The International Council for Harmonisation (ICH) Q10 guideline on Pharmaceutical Quality Systems (PQS) establishes a harmonized, life‐cycle approach to quality management in drug manufacturing.

Jul 23, 2025 · Explore ICH Q10 Pharmaceutical Quality System, lifecycle stages, PQS elements, management responsibilities, and how eQMS supports compliance and improvement.

Oct 1, 2024 · To maintain the highest standards of quality, the International Council for Harmonization (ICH) developed the Q10 guideline, which provides a comprehensive framework for a …

ICH Q10 aims to promote a paradigm shift from discrete GMP compliance procedures at each stage of the product lifecycle to a comprehensive quality systems approach over the lifecycle of the product

Nov 27, 2024 · Learn the essential components of ICH Q10, benefits of implementation, and practical steps for aligning your QMS with its requirements.

Nov 29, 2025 · Discover what is ICH Q10, the global guideline for a Pharmaceutical Quality System (PQS). Learn how it drives continuous improvement and ensures drug quality throughout the lifecycle.