List of ICH Quality Guidelines for Pharmaceutical Industry

Table of Contents

Revised ICH (International Conference on Hormonisation) Quality Guidelines in pharmaceuticals are given below:   
Q1A (R2) – Stability Testing of New Drug Substances and Products
Q1 B – Stability Testing : Photo Stability 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 Application in Climatic Zones III and IV
Q2 (R1) – Validation of Analytical Procedures : Text and Methodology
Q3A (R2) – Impurities in New Drug Substances
Q3B (R2) – Impurities in New Drug Products
Q3C (R5) – Impurities : Guideline for Residual Solvents
Q3D – Impurities : Guideline for Elemental Impurities 
Q4A – Pharmacopoeial Harmonisation

The pharmacopoeial authorities, working together through the Pharmacopoeial Discussion Group (PDG), have been closely involved with the work of ICH since the outset and harmonisation between the major pharmacopoeias, which started before ICH, has proceeded in parallel.

Q4B – Evaluation and Recommendation of Pharmacopoeial Text 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 Preparation General Chapter 
Q5A(R1) – Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5B – Quality of Biotechnology Products :
Q5C – Quality of Biotechnology Products :Quality of Biotechnological
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 – Specifications : Test Procedure and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Q6B – Specifications : Test Procedure and Acceptance Criteria for Biotechnological/Biological
Q7 – Good Manufacturing Guide for Active Pharmaceutical Ingredients
Q8(R2) – Pharmaceutical Development
Q9 – Quality Risk Management
Q10 – Pharmaceutical Quality System
Q11 – Development and Manufacture of Drug Substances (Chemical Entities Biotechnological/Biological Entities)
Q12 – Life Cycle Management

Q13 -EWG Continuous Manufacturing of Drug Substances and Drug Products

Q2(R2)/Q14EWGAnalytical Procedure Development and Revision of Q2 (R1) Analytical Validation

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