Q1AR2 – Q1F
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Stability
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Q1A (R2)
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Stability Testing of New Drug Substances and Products
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Q1 B
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Stability Testing : Photo Stability Testing of New Drug Substances and Products
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Q1C
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Stability Testing for New Dosage Forms
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Q1D
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Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
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Q1 E
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Evaluation of Stability Data
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Q1F
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Stability Data Package for Registration Application in Climatic Zones III and IV
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Q2 (R1)
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Validation of Analytical Procedures : Text and Methodology
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Q3AR2 – Q3D
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Impurities
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Q3A (R2)
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Impurities in New Drug Substances
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Q3B (R2)
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Impurities in New Drug Products
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Q3C (R5)
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Impurities : Guideline for Residual Solvents
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Q3D
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Impurities : Guideline for Elemental Impurities
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Q4-Q4B
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Pharmacopoeias
|
Q4
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Pharmacopoeias
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Q4A
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Pharmacopoeial Harmonisation
|
Q4B
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Evaluation and Recommendation of Pharmacopoeial Text for use in the ICH Regions
|
Q4B Annex 1R1
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Residue on Ignition /Sulphated Ash General Chapter
|
Q4B Annex 2R1
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Test for Extractable Volume of Parenteral Preparation General Chapter
|
Q4B Annex 3R1
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Test for Particulate Contamination : Sub-Visibal Particales General Chapter
|
Q4B Annex 4AR1
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Microbiological Examination of Non-Sterile Products : Microbial Enumeration Tests General Chapter
|
Q4B Annex 4BR1
|
Microbiological Examination of Non-Sterile Products : Test for Specified Micro-Organism General Chapter
|
Q4B Annex 4CR1
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Microbiological Examination of Non-Sterile Products : Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical use General Chapter
|
Q4B Annex 5R1
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Disintegration Test General Chapter
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Q4B Annex 6 R1
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Uniformity of Dosage Units General Chapter
|
Q4B Annex 7R2
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Dissolution Test General Chapter
|
Q4B Annex 8R1
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Stability Test General Chapter
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Q4B Annex 9R1
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Tablet Friability General Chapter
|
Q4B Annex 10R1
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Polyacrylamide Gel Electrophoresis General Chapter
|
Q4B Annex 11
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Capillary Electrophoresis General Chapter
|
Q4B Annex 12
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Analytical Sieving General Chapter
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Q4B Annex 13
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Bulk Density and Tapped Density of Powders General Chapter
|
Q4B Annex 14
|
Bacterial Endotoxin Test General Chapter
|
Q5AR1-Q5E
|
Quality of Biotechnological Products
|
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
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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
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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
|
Q8R2
|
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
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