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ICH Q Guidelines
#1 · November 1, 2024, 2:46 am
Please share the list of ICH Q Guidelines with their application in pharmaceutical industry.
#2 · November 14, 2024, 5:12 am
List of ICH Q Guidelines:
- ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
- ICH Q1B – Photostability Testing of New Drug Substances and Products
- ICH Q2(R1) – Validation of Analytical Procedures: Text and Methodology
- ICH Q3A(R2) – Impurities in New Drug Substances
- ICH Q3B(R2) – Impurities in New Drug Products
- ICH Q5C – Quality of Biotechnological Products | Stability Testing for Biotechnological/ Biological Products
- ICH Q6A – Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ICH Q8(R2) – Pharmaceutical Development
- ICH Q9 – Quality Risk Management
- ICH Q10 Pharmaceutical Quality System
- ICH Q11 – Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
For details: https://pharmadigests.com/ich-quality-guidelines/
