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 Pha...
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[@bkalyan7555]

Good contemt..

[@TooShikiton11]

Thanks for sharing this on linkdin,
Really appreciate the great work....

[@proftalks1680]

Thanks for Support

[@sawant1853]

Nice sir please keep sharing

[@proftalks1680]

Thanks for supporting

[@kristamcharan]

Very informative and useful 👍👏

[@proftalks1680]

Thanks for all your support

[@ramyav5054]

Very nice and easy to understand. please make a presentation on ICH Q7 & Q8.

[@proftalks1680]

Thanks🙏

[@kristamcharan]

Request you to make a presentation on iso 9001:2015 also 🙏

[@proftalks1680]

Thanks for suggestion. Will surely do it.

[@kevbutch4832]

Hello, Thank you but you only read the text. You should give exemples to clearly explain the aspects of the text. Regards

[@proftalks1680]

Thanks for recommended.. Will improve