8:43 AM
Leo Group India
The “Q-Family”
Q 1 – Stability Testing
Q 2 – Analytical Validation
Q 3 – Impurities
Q 4 – Pharmacopoeias
Q 5 – Biotechnological Products
Q 6 – Specifications
Q 7 – Good Manufacturing Practices
Q 8 – Pharmaceutical Development
Q 9 – Quality Risk Management
Q 10 – Pharmaceutical Quality System
ICH Q 1 – Stability Testing
A set of originally five guidelines (Q1A to Q1F)
defining
- General aspects of stability testing (storage
conditions, batch size and number, length of
time...)
- Photostability
- Application to new dosage forms
- Possibilities for reduced test designs
(bracketing and matrixing)
Dr. Susanne Keitel, 12/08
©2008 EDQM, Council of Europe, All rights reserved
I
ICH Q 1 – Stability Testing
- Statistical evaluation of stability data
and possibilities for extrapolation
- Storage conditions for stability testing in
climatic zones III and IV (withdrawn 
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