ICH Stability Q1A - Q11

• 
  
  

  Stability Q1A - Q1F

  
  

  • Q1A(R2)Stability Testing of New Drug Substances and ProductsQ1A
  • Q1BStability Testing : Photostability Testing of New Drug Substances and Products
  • Q1CStability Testing for New Dosage Forms
  • Q1DBracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
  • Q1EEvaluation of Stability Data
  • Q1FStability Data Package for Registration Applications in Climatic Zones III and IV

  
  

   

  Analytical Validation Q2

  Q2(R1)Validation of Analytical Procedures: Text and MethodologyQ2A, Q2B

  Finalised Guidelines:
  October 1994/November 1996

  Q2(R1)

  Description: The tripartite harmonised ICH Guideline on Text (previously coded Q2

  
  

  Impurities Q3A - Q3D

  • Q3A(R2)Impurities in New Drug Substances
  • Q3B(R2)Impurities in New Drug Products
  • Q3C(R5)Impurities: Guideline for Residual SolventsQ3C, Q3C(M)
  • Q3DImpurities: Guideline for Metal Impurities

  
  

  Pharmacopoeias Q4 - Q4B

  • Q4Pharmacopoeias
  • Q4APharmacopoeial Harmonisation
  • Q4BEvaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
  • Q4B Annex 1R1Residue on Ignition/Sulphated Ash General Chapter
  • Q4B Annex 2R1Test for Extractable Volume of Parenteral Preparations General Chapter
  • Q4B Annex 3R1Test for Particulate Contamination: Sub-Visible Particles General Chapter
  • Q4B Annex 4AR1Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
  • Q4B Annex 4BR1Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter
  • Q4B Annex 4CR1Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
  • Q4B Annex 5R1Disintegration Test General Chapter
  • Q4B Annex 6R1Uniformity of Dosage Units General Chapter
  • Q4B Annex 7R2Dissolution Test General Chapter
  • Q4B Annex 8R1Sterility Test General Chapter
  • Q4B Annex 9R1Tablet Friability General Chapter
  • Q4B Annex 10R1Polyacrylamide Gel Electrophoresis General Chapter
  • Q4B Annex 11Capillary Electrophoresis General Chapter
  • Q4B Annex 12Analytical Sieving General Chapter
  • Q4B Annex 13Bulk Density and Tapped Density of Powders General Chapter
  • Q4B Annex 14Bacterial Endotoxins Test General Chapter
  • Q4B FAQsFrequently Asked Questions

  
  

  Quality of Biotechnological Products Q5A - Q5E

  • Q5A(R1)Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginQ5A
  • Q5BAnalysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
  • Q5CStability Testing of Biotechnological/Biological Products
  • Q5DDerivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
  • Q5EComparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

   Specifications Q6A- Q6B

  • Q6ASpecifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
  • Q6BSpecifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

  
  

  Good Manufacturing Practice Q7

  • Q7Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsQ7A
  • Q7 Q&AsQuestions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

  
  

  Pharmaceutical Development Q8

  • Q8(R2)Pharmaceutical Development
  • Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation

  Quality Risk Management Q9

  • Q9Quality Risk Management
  • Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation

   

  
  

  Pharmaceutical Quality System Q10

  • Q10Pharmaceutical Quality System
  • Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation

  
  

  Development and Manufacture of Drug Substances Q11

  Q11Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

  Finalised Guideline:
  May 2012

  
  

  
  

  Q11

  Concept Paper

  Business Plan

  
  

  
  For download all files click here Zip with all ICH Quality Guidelines in word format

Posted in: ICH