ICH Q10 Guidance for Pharmaceutical Quality System | Guideline for Pharmaceutical Industry
12.4 هزار بار بازدید -
3 سال پیش
-
Popularly known as ICH Q10
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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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...
About the channel:
The channel has been developed with view of sharing information on Pharmaceutical Guidelines & Guidance..
Kindly subscribe to channel at: @proftalks1680
Other Useful Videos:
1. Interview Question: 'Describe Yourself' OR 'Tell me something about yourself': How to introduce youself in interview...
2. 5 Step formula for interview preparation: How to prepare for interview | Tips f...
3. Interview Dont's, things you should not talk in interview: Don'ts of Interview | Things not to t...
3 سال پیش
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