A Adresses A Adresses
A Adresses
B National Bodies and Pharmaceutical Associations B National Bodies and Pharmaceutical Associations
B National Bodies and Pharmaceutical Associations
C EU Directives and Guidelines C EU Directives and Guidelines
C EU Directives and Guidelines
D USA: CFR and FDA Guidelines D USA: CFR and FDA Guidelines
D USA: CFR and FDA Guidelines
E ICH Guidelines E ICH Guidelines
E ICH Guidelines
E.1.A ICH Q1A(R2): Stability Testing of New Drug Substances and Products E.1.A ICH Q1A(R2): Stability Testing of New Drug Substances and Products
E.1.A ICH Q1A(R2): Stability Testing of New Drug Substances and Products
E.1.B ICH Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products E.1.B ICH Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products
E.1.B ICH Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products
E.1.C ICH Q1C: Stability Testing for New Dosage Forms E.1.C ICH Q1C: Stability Testing for New Dosage Forms
E.1.C ICH Q1C: Stability Testing for New Dosage Forms
E.1.D ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products E.1.D ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
E.1.D ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
E.1.E ICH Q1E: Evaluation of Stability Data E.1.E ICH Q1E: Evaluation of Stability Data
E.1.E ICH Q1E: Evaluation of Stability Data
E.2 ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology E.2 ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology
E.2 ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology
E.3.A ICH Q3A(R2): Impurities in New Drug Substances E.3.A ICH Q3A(R2): Impurities in New Drug Substances
E.3.A ICH Q3A(R2): Impurities in New Drug Substances
E.3.B ICH Q3B(R2): Impurities in New Drug Products E.3.B ICH Q3B(R2): Impurities in New Drug Products
E.3.B ICH Q3B(R2): Impurities in New Drug Products
E.3.C ICH Q3C(R6): Impurities: Guideline for Residual Solvents E.3.C ICH Q3C(R6): Impurities: Guideline for Residual Solvents
E.3.C ICH Q3C(R6): Impurities: Guideline for Residual Solvents
Document History
Document History
Table of Contents
Table of Contents
Part I: Impurities: Guideline for Residual Solvents Part I: Impurities: Guideline for Residual Solvents
Part I: Impurities: Guideline for Residual Solvents
Part II: Impurities: Residual Solvents (Maintenance) PDE for Tetrahydrofuran Part II: Impurities: Residual Solvents (Maintenance) PDE for Tetrahydrofuran
Part II: Impurities: Residual Solvents (Maintenance) PDE for Tetrahydrofuran
Part III: Impurities: Residual Solvents (Maintenance) PDE for N-Methylpyrrolidone (NMP) Part III: Impurities: Residual Solvents (Maintenance) PDE for N-Methylpyrrolidone (NMP)
Part III: Impurities: Residual Solvents (Maintenance) PDE for N-Methylpyrrolidone (NMP)
Part IV: Impurities: Residual Solvents (Maintenance) PDE for Cumene Part IV: Impurities: Residual Solvents (Maintenance) PDE for Cumene
Part IV: Impurities: Residual Solvents (Maintenance) PDE for Cumene
Part V: Impurities: Residual Solvents (Maintenance) PDE for Triethylamine and PDE of Methylisobutylketone Part V: Impurities: Residual Solvents (Maintenance) PDE for Triethylamine and PDE of Methylisobutylketone
Part V: Impurities: Residual Solvents (Maintenance) PDE for Triethylamine and PDE of Methylisobutylketone
E.3.D ICH Q3D (R1): Guideline for Elemental Impurities E.3.D ICH Q3D (R1): Guideline for Elemental Impurities
E.3.D ICH Q3D (R1): Guideline for Elemental Impurities
E.4 ICH Q4: Pharmacopoeias
E.4 ICH Q4: Pharmacopoeias
E.4.A ICH Q4A: Pharmacopoeial Harmonisation
E.4.A ICH Q4A: Pharmacopoeial Harmonisation
E.4.B ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions E.4.B ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
E.4.B ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
E.4.B.1 ICH Q4B Annex 1: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash – General Chapter E.4.B.1 ICH Q4B Annex 1: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash – General Chapter
E.4.B.1 ICH Q4B Annex 1: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash – General Chapter
E.4.B.2 ICH Q4B Annex 2: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations – General Chapter E.4.B.2 ICH Q4B Annex 2: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations – General Chapter
E.4.B.2 ICH Q4B Annex 2: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations – General Chapter
E.4.B.3 ICH Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles – General Chapter E.4.B.3 ICH Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles – General Chapter
E.4.B.3 ICH Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles – General Chapter
E.4.B.4.1 ICH Q4B Annex 4A: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Microbiological Examination of Non-Sterile Products: Microbial Enumerations Tests – General Chapter E.4.B.4.1 ICH Q4B Annex 4A: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Microbiological Examination of Non-Sterile Products: Microbial Enumerations Tests – General Chapter
E.4.B.4.1 ICH Q4B Annex 4A: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Microbiological Examination of Non-Sterile Products: Microbial Enumerations Tests – General Chapter
E.4.B.4.2 ICH Q4B Annex 4B : Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms – General Chapter E.4.B.4.2 ICH Q4B Annex 4B : Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms – General Chapter
E.4.B.4.2 ICH Q4B Annex 4B : Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms – General Chapter
E.4.B.4.3 ICH Q4B Annex 4C: 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 E.4.B.4.3 ICH Q4B Annex 4C: 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
E.4.B.4.3 ICH Q4B Annex 4C: 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
E.4.B.5 ICH Q4B Annex 5: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test – General Chapter E.4.B.5 ICH Q4B Annex 5: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test – General Chapter
E.4.B.5 ICH Q4B Annex 5: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test – General Chapter
E.4.B.6 ICH Q4B Annex 6: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units – General Chapter E.4.B.6 ICH Q4B Annex 6: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units – General Chapter
E.4.B.6 ICH Q4B Annex 6: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units – General Chapter
E.4.B.7 ICH Q4B Annex 7: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test – General Chapter E.4.B.7 ICH Q4B Annex 7: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test – General Chapter
E.4.B.7 ICH Q4B Annex 7: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test – General Chapter
E.4.B.8 ICH Q4B Annex 8: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test – General Chapter E.4.B.8 ICH Q4B Annex 8: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test – General Chapter
E.4.B.8 ICH Q4B Annex 8: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test – General Chapter
E.4.B.9 ICH Q4B Annex 9: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability – General Chapter E.4.B.9 ICH Q4B Annex 9: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability – General Chapter
E.4.B.9 ICH Q4B Annex 9: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability – General Chapter
E.4.B.10 ICH Q4B Annex 10: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis – General Chapter E.4.B.10 ICH Q4B Annex 10: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis – General Chapter
E.4.B.10 ICH Q4B Annex 10: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis – General Chapter
E.5.A ICH Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin E.5.A ICH Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
E.5.A ICH Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
E.5.B ICH Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of R-DNA Derived Protein Products E.5.B ICH Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of R-DNA Derived Protein Products
E.5.B ICH Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of R-DNA Derived Protein Products
E.5.C ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products E.5.C ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
E.5.C ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
E.5.D ICH Q5D: Derivation and Characterisation of Cell Substrates used for Production of Biotechnological/Biological Products E.5.D ICH Q5D: Derivation and Characterisation of Cell Substrates used for Production of Biotechnological/Biological Products
E.5.D ICH Q5D: Derivation and Characterisation of Cell Substrates used for Production of Biotechnological/Biological Products
E.5.E ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process E.5.E ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
E.5.E ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
E.6.A ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances E.6.A ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
E.6.A ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
E.6.B ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products E.6.B ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
E.6.B ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
E.7 ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients E.7 ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
E.7 ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
E.7.1 ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Questions and Answers E.7.1 ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Questions and Answers
E.7.1 ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Questions and Answers
E.8 ICH Q8 (R2): Pharmaceutical Development E.8 ICH Q8 (R2): Pharmaceutical Development
E.8 ICH Q8 (R2): Pharmaceutical Development
E.9 ICH Q9: Quality Risk Management E.9 ICH Q9: Quality Risk Management
E.9 ICH Q9: Quality Risk Management
E.10 ICH Q10: Pharmaceutical Quality System E.10 ICH Q10: Pharmaceutical Quality System
E.10 ICH Q10: Pharmaceutical Quality System
E.10.1 Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4) E.10.1 Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4)
E.10.1 Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4)
E.10.2 ICH Quality Implementation Working Group Points to Consider (R2) ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation E.10.2 ICH Quality Implementation Working Group Points to Consider (R2) ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
E.10.2 ICH Quality Implementation Working Group Points to Consider (R2) ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
E.11 ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) E.11 ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
E.11 ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
E.11.1 ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers E.11.1 ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers
E.11.1 ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers
E.12 Draft Version ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management E.12 Draft Version ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
E.12 Draft Version ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
F PIC/S Guidelines F PIC/S Guidelines
F PIC/S Guidelines
G GMP of other Regions G GMP of other Regions
G GMP of other Regions
H WHO Guidelines H WHO Guidelines
H WHO Guidelines
as of 2019 - 10 - 24
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