ICH Q10 Pharmaceutical Quality System

• By: Staff Editor
• Date: November 27, 2016
• Source: http://www.fda.gov

ICH Q10 Pharmaceutical Quality System

Referred to as the pharmaceutical quality system, this internationally harmonized guidance is defined to assist pharmaceutical manufacturers by describing a model for an effective quality management system. In this guidance, the ICH Q10 model is referred to as the pharmaceutical quality system.

In the interest of public health, the ICH Q10 establishes regulatory and industry authorities’ support of an operative pharmaceutical quality system by enhancing the quality and availability of medicines across the globe. Implementation of ICH Q10 during the product lifecycle must facilitate innovation and continual improvement, and strengthen the link between pharmaceutical development and manufacturing activities.

Among other key areas, this guidance will look at:

• Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7
• Relationship of ICH Q10 to Regulatory Approaches
• ICH Q10 Objectives
• Pharmaceutical Quality System Elements
• Application of Process Performance and Product Quality Monitoring System Throughout the Product Lifecycle
• Application of Corrective Action and Preventive Action (CAPA) System Throughout the Product Lifecycle
• Application of Change Management System Throughout the Product Lifecycle
• Continual Improvement of the Pharmaceutical Quality System

Related Training:

A Comparison of ICH Q-10 Quality System and the FDA's Quality Systems Approach (QSA) to the Pharmaceutical cGMPs

ICH Q10 - Moving From GMPs to a Pharmaceutical Quality System