Category: ICH Guidelines

Here’s a list of ICH Quality Guidelines along with the direct hyperlinks to each guideline on the ICH website:

1. Q1: Stability Testing

• Q1A(R2) Stability Testing of New Drug Substances and Products-
• Q1B Photostability Testing of New Drug Substances and Products
• Q1C Stability Testing for New Dosage Forms
• Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
• Q1E Evaluation of Stability Data
• Q1F Stability Data Requirements for Biotechnological/Biological Products

2. Q2: Analytical Validation

• Q2(R1) Validation of Analytical Procedures: Text and Methodology

3. Q3: Impurities

• Q3A(R2) Impurities in New Drug Substances
• Q3B(R2) Impurities in New Drug Products
• Q3C(R8) Impurities: Residual Solvents
• Q3D Guideline for Elemental Impurities

4. Q4: Pharmaceutical Development

• Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

5. Q5: Biotechnological Products

• Q5A(R1) Stability Testing of Biotechnological/Biological Products
• Q5B Analysis of the Stability of Biotechnological/Biological Products
• Q5C Good Manufacturing Practice (GMP) for Biotechnological/Biological Products
• Q5D Derivation and Characterization of Cell Substrates Used for Production of Biotechnological Products

6. Q6: Specifications

• Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
• Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

7. Q7: Good Manufacturing Practice (GMP)

• Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients (API)

8. Q8: Pharmaceutical Development

• Q8(R2) Pharmaceutical Development

9. Q9: Quality Risk Management

• Q9 Quality Risk Management

10. Q10: Pharmaceutical Quality System

• Q10 Pharmaceutical Quality System

11. Q11: Development and Manufacture of Drug Substances

• Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

12. Q12: Pharmaceutical Product Lifecycle Management

• Q12 Pharmaceutical Product Lifecycle Management

13. Q13: Continuous Manufacturing

• Q13 Continuous Manufacturing of Drug Substances and Drug Products

Note:- These links direct you to the official ICH website where you can access the full texts of each guideline. Each page contains the relevant guideline documents, details, and updates related to that particular quality standard.