ICH Guidelines

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Following is the list of guidelines:

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 - Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products

Q1D - Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

Q1E - Evaluation for Stability Data

Q1F - Stability Data Package for Registration Applications 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

Q4 - Pharmacopoeia

Q4A - Pharmacopoeial Harmonization

Q4B - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

Q4B Annex 4A(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumerations Tests

Q4B Annex 4B(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms

Q4B Annex 4C(R1) - 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

Q4B Annex 1(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash

Q4B Annex 2(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations

Q4B Annex 3(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles

Q4B Annex 5(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test

Q4B Annex 6(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units

Q4B Annex 7(R2) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test

Q4B Annex 8(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test

Q4B Annex 9(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability

Q4B Annex 10(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis

Q4B Annex 11 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis

Q4B Annex 12 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving

Q4B Annex 13 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders

Q4B Annex 14 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Test

Q4B - 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

Q5B - Quality of Biotechnological Products: 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

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

Q8(R2) - Pharmaceutical Development

Q9 - Quality Risk Management

Q10 - Pharmaceutical Quality System

Q11 - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

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