ICH Q10 Guidance for Pharmaceutical Quality System | Guideline for Pharmaceutical Industry

Popularly known as ICH Q10 PQS Model. It is 'Q10 Pharmaceutical Quality System' ICH Guidance for Pharmaceutical Industry published in April 2009.

This Guidance is published by ICH (including USFDA, EU & Japan Authorities) for establishing an effective Pharmaceutical Quality System.

The Guidance states3 objectives:
1. Product Realization
2. Establishing & Maintaining State of Control
3. Continued Improvement

It states two enablers:
1. Knowledge management
2. Quality Risk Management

The Guidance define 4 elements:
1. Process Performance & Product Quality
2. Change Management
3. Corrective & Preventive Actions
4. Management Review

This guidance is based on ISO 9000:2015 concepts and complements the CGMP.

It is also similar to USFDA Guidance on 'Quality System Approach to Pharmaceutical CGMP Regulations' USFDA Guidance issued on September 2006.    • USFDA Guidance for Pharmaceutical Qua...  

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