Tag: ICH Quality 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

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
• Q3E Guideline for extractables and leachables

4. Q4: Pharmacopoeias

• Q4A Pharmacopoeial Hormonisation
• 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.
• Q5E Comparability of  Biotechnological Products subject to changes in their manufacturing Process.

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

• Q9: Quality Risk Management

• Q9: Quality Risk Management

• 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

14. Q14: Analytical Procedure Development

• Q14 Analytical Procedure Development

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.