ICH Quality Guidelines

Important achievements in pharmaceutical quality harmonization include harmonized stability testing protocols, established impurity testing thresholds, and a flexible, risk-based quality management approach supported by Good Manufacturing Practice (GMP) principles.

Q1A - Q1F Stability

Q1A(R2) Stability Testing Guide

Q1B Photostability Testing Guide

Q1C Stability Testing for New Dosage Forms

Q1D ICH Q1D Bracketing and Matrixing Guide

Q1E Stability Data Evaluation Guide

Q1F WHO Stability Guideline Explained

Q1 EWG Stability Testing of Drug Substances and Drug Products

Q2 Analytical Validation

Q2(R2) Revision of Q2(R1) Analytical Validation

Q2(R2)/Q14 Training on Validation of Analytical Procedures and Q14: Analytical Procedure Development

Q3A - Q3E Impurities

Q3A(R2) Impurities in New Drug Substances

Q3b Impurities in New Drug Products

Q3C(R8) Impurities: Guideline for Residual Solvents

Q3D(R2) Guideline for Elemental Impurities

Q3E Assessment and Control of Extractables and Leachables (E&L)

Q4A - Q4B Pharmacopoeias

Q4A Pharmacopoeial Harmonisation

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

Q5A - Q5E Quality of Biotechnological Products

Q5A(R2) 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 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