ICH guidlines.

Quality Guidelines
New Codification as per November 2005

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


Analytical Validation
Q2(R1) New title: Validation of Analytical Procedures: Text and Methodology
Previously: Text on Validation of Analytical Procedures Q2A
Validation of Analytical Procedures: Methodology (in Q2(R1)) Q2B

Impurities
Q3A(R2) Impurities in New Drug Substances
Q3A(R)
Q3B(R2) Impurities in New Drug Products
Q3B(R)
Q3C(R4) Impurities: Guideline for Residual Solvents
Q3C
Impurities: Guideline for Residual Solvents (Maintenance)
PDE for Tetrahydrofuran (in Q3C(R3)) Q3C(M)
PDE for N-Methylpyrrolidone (in Q3C(R3)) Q3C(M)
PDE for Cumene

Procedures are described here


Pharmacopoeias
Q4 Pharmacopoeias

Q4A Pharmacopoeial Harmonisation

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


Q4B
Annex 1(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Residue on Ignition/Sulphated Ash General Chapter


Q4B
Annex 2(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Test for Extractable Volume of Parenteral Preparations General Chapter


Q4B
Annex 3(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Test for Particulate Contamination: Sub-Visible Particles General Chapter


Q4B
Annex 4A(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter


Q4B
Annex 4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter

Q4B
Annex 4C(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

Q4B
Annex 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Disintegration Test General Chapter

Q4B
Annex 6(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Uniformity of Dosage Units General Chapter

Q4B
Annex 7(R2) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Dissolution Test General Chapter

Q4B
Annex 8(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Test for Sterility General Chapter

Q4B
Annex 9(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Tablet Friability General Chapter

Q4B
Annex 10(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Polyacrylamide Gel Electrophoresis General Chapter

Q4B
Annex 11 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Capillary Electrophoresis General Chapter

Q4B
Annex 12 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Analytical Sieving General Chapter

Q4B
Annex 13 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Bulk Density and Tapped Density of Powders General Chapter

Q4B
Annex 14 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
on Bacterial Endotoxins Test General Chapter


Quality of Biotechnological Products
Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5A
Q5B Quality of Biotechnological Products : 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


Specifications
Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including Decision Trees)

Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products


Good Manufacturing Practice
Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Q7A

Pharmaceutical Development
Q8(R2) Pharmaceutical Development


Quality Risk Management
Q9 Quality Risk Management


Pharmaceutical Quality System
Q10 Pharmaceutical Quality System


Q8/9/10 Q&As (R4) Q8/Q9/Q10 - Questions & Answers document