ICH Q10: Quality Management Systems
The International Conference on Harmonisation recently closed consultation on its draft quality guidance, ICH Q10 Pharmaceutical Quality Systems. Adoption of the ICH Q10 guidance could come in Q1 2008.
It is proposed that pharmaceutical companies that employ quality by design (ICH Q8) and risk management processes (ICH Q9) will have a quality management system to manage administration, change, and continual improvements.
|
QM Element |
ICH Q10 (Draft) |
ISO 9000:2000 |
|
Quality Policy |
Chapter 2.2 |
Chapter 5.3 |
|
Corrective Actions |
Chapter 3.2 ii |
Chapter 8.5.2 |
|
Preventive Actions |
Chapter 3.2 ii |
Chapter 8.5.3 |
|
Improvements |
Chapter 4 |
Chapter 8.5 |
|
Management Review |
Chapter 2.6 |
Chapter 5.6 |
|
Management Commitment |
Chapter 2.1 |
Chapter 5.1 |
Download ICH Guidelines from http://it-validation.eu/downloads/ich/index.php or at www.ich.org.
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