ICH Quality Guidelines

ICH Quality Guidelines

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Q1A-Q1F Stability:

Q1A(R2) Stability Testing of New Drug Substances and Products

Q1B Stability Testing : 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 Package for Registration Applications in Climatic Zones III and IV

Q2 Analytical Validation:

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

Q3A-Q3E Impurities:

Q3A(R2) Impurities in New Drug Substances 

Q3B(R2) Impurities in New Drug Products

Q3C(R8)Guideline for Residual Solvents

Q3D(R2) Guideline for Elemental Impurities

Q4A-Q4B Pharmacopoeias:

Q4A Pharmacopoeial Harmonisation

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

Q4B Annex 1 (R1) Residue on Ignition/Sulphated Ash General Chapter

Q4B Annex 2 (R1) Test for Extractable Volume of Parenteral Preparations General Chapter

Q4B Annex 3 (R1) Test for Particulate Contamination: Sub-Visible Particles General Chapter

Q4B Annex 4A (R1) Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

Q4B Annex 4B (R1) Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter

Q4B Annex 4C (R1) Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

Q4B Annex 5 (R1) Disintegration Test General Chapter

Q4B Annex 6 Uniformity of Dosage Units General Chapter

Q4B Annex 7 (R2) Dissolution Test General Chapter

Q4B Annex 8 (R1) Sterility Test General Chapter

Q4B Annex 9 (R1) Tablet Friability General Chapter

Q4B Annex 10 (R1) Polyacrylamide Gel Electrophoresis General Chapter

Q4B Annex 11 Capillary Electrophoresis General Chapter

Q4B Annex 12 Analytical Sieving General Chapter

Q4B Annex 13 Bulk Density and Tapped Density of Powders General Chapter

Q4B Annex 14 Bacterial Endotoxins Test General Chapter

Q5A-Q5E Quality of Biotechnological Products:

Q5A(R1)Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Q5B Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

Q6A-Q6B 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

Q7 Good Manufacturing Practice:

Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Q7 Q&As Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Q8 Pharmaceutical Development:

Q8(R2) Pharmaceutical Development

Q9 Quality Risk Management:

Q9(RI) Quality Risk Management

Q10 Pharmaceutical Quality System:

Q10 Pharmaceutical Quality System

Q11 Development and Manufacture of Drug Substances:

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

Q12 Lifecycle Management:

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Q13 Continuous Manufacturing of Drug Substances and Drug Products:

Q13 Continuous Manufacturing of Drug Substances and Drug Products

Q14 Analytical Procedure Development

Source from ICH