Q1/Q5C EWG Targeted Revisions of the ICH Stability Guideline Series
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Q12 IWG Training on Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management
Q13 Continuous Manufacturing of Drug Substances and Drug Products
Q13 IWG Training on Continuous Manufacturing of Drug Substances and Drug Products
Q14 Analytical Procedure Development
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
Q2(R1) Validation of Analytical Procedures: Text and Methodology
Q2(R2) Revision of Q2(R1) Analytical Validation
Q2(R2)/Q14 IWG Training on Validation of Analytical Procedures and Q14: Analytical Procedure Development
Q3A(R2) Impurities in New Drug Substances
Q3B(R2) Impurities in New Drug Products
Q3C(R10) Maintenance EWG Maintenance of the Guideline for Residual Solvents
Q3C(R7) Maintenance of the Guideline for Residual Solvents
Q3C(R8) Guideline for Residual Solvents
Q3C(R9) Guideline for Residual Solvents
Q3D Guideline for Elemental Impurities
Q3D training Implementation of Guideline for Elemental Impurities
Q3D(R2) Guideline for Elemental Impurities
Q3D(R3) Maintenance EWG Maintenance of the Guideline for Elemental Impurities
Q3E EWG Impurity: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics
Q4A Pharmacopoeial Harmonisation
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Q4B Annex 1(R1) Residue on Ignition/Sulphated Ash General Chapter
Q4B Annex 10(R1) Polyacrylamide Gel Electrophoresis General Chapter
Q4B Annex 11 Capillary Electrophoresis General Chapter
Q4B Annex 12 Analytical Sieving General Chapter
Q4B Annex 13 Bulk Density and Tapped Density of Powders General Chapter
Q4B Annex 14 Bacterial Endotoxins Test General Chapter
Q4B Annex 2(R1) Test for Extractable Volume of Parenteral Preparations General Chapter
Q4B Annex 3(R1) Test for Particulate Contamination: Sub-Visible Particles General Chapter
Q4B Annex 4A(R1) Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
Q4B Annex 4B(R1) Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter
Q4B Annex 4C(R1) Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
Q4B Annex 5(R1) Disintegration Test General Chapter
Q4B Annex 6 Uniformity of Dosage Units General Chapter
Q4B Annex 7(R2) Dissolution Test General Chapter
Q4B Annex 8(R1) Sterility Test General Chapter
Q4B Annex 9(R1) Tablet Friability General Chapter
Q4B FAQs Frequently Asked Question
Q4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5A(R2) IWG Training on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5B 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
Q6(R1) EWG Revision of the Specifications Guidelines
Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Q7 Q&As Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Q8(R2) Pharmaceutical Development
Q8/9/10 Q&As (R4) Q8/Q9/Q10 – Implementation
Q9(R1) Quality Risk Management
Q9(R1) IWG 2006-2010 Training on Quality Risk Management
Q9(R1) Training Group Quality Risk Management Quality Risk Management Training Group