International Conference on Harmonization (ICH)

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Quality - Adopted Guidelines

Topic Q1A, Step 5 Note for Guidance on Stability Testing of New Drug Substances and Products (CPMP/ICH/2736/99 ( Revision of CPMP/ICH/380/95), - (approval of second revison by CPMP February 2003)

Topic Q1A, Step 5 Note for Guidance on Stability Testing: Stability Testing of New Drug Substances and Products (CPMP/ICH/380/95 - adopted Dec. 93)

Topic Q1B, Step 4 Note for Guidance on Photostability testing of New Active Substances and Medicinal products (CPMP/ICH/279/95 - adopted December 96)

Topic Q1C, Step 4 Note for Guidance on Stability Testing: Requirements for New Dosage Forms (CPMP/ICH/280/95 - adopted December 96)

Topic Q1D, Step 5 Note for Guidance on Bracketing and Matrixing Designs for Stability Testing of Drug Subtances and Drug Products (CPMP/ICH/4104/00 - adopted February 2002) - Replaces NFG on Bracketing and Matrixing CPMP/ICH/ 157/96

Topic Q2A, Step 5 Note for Guidance on Validation of Analytical Methods: Definitions and Terminology (CPMP/ICH/381/95 - adopted Nov. 94)

Topic Q3B, Step 2 Note for Guidance on Impurities in New Drug Products (CPMP/ICH/2738/99 (Revision of CPMP/ICH/282/95), approval by CPMP 2003)

Topic Q1E, Step 3 Note for Guidance on Evaluation of Stability Data (CPMP/ICH/420/02 - final approval by CPMP February 2003)

Topic Q1F, Step 3 Note for Guidance on Stability Data Package for Registration in Climatic Zones III and IV (CPMP/ICH/421/02 - final approval by CPMP February 2003)

Topic Q2B, Step 4 Note for Guidance on Validation of Analytical Procedures: Methodology (CPMP/ICH/281/95 - adopted December 96)

Topic Q3A, Step 5 Note for Guidance on Impurities Testing: Impurities in New Drug Substances (CPMP/ICH/2737/99 (Revision of CPMP/ICH/142/95) - adopted February 2002)

Topic Q3A, Step 5 Note for Guidance on Impurities Testing: Impurities in New Drug Substances (CPMP/ICH/142/95 - adopted May. 95)

Topic Q3B, Step 4 Note for Guidance on Impurities in New Medicinal Products(CPMP/ICH/282/95 adopted December 96)

Topic Q3C(M) Step 4 Note for Guidance on Impurities: Residual Solvents - Permissible Daily Exposure (TDE) for Tetrahydrofuran and N. Methylpyyrolidone (CPMP/ICH/1940/00 - CPMP Adopted 2002) (corregendum to calculation formula for NMP)

Topic Q3C, Step 4 Note for Guidance on Impurities: Residual Solvents (CPMP/ICH/283/95 - adopted Sept. 97)

Topic Q3C(M), Step 5 Maintenance for Note for Guidance on Impurities:Residual Solvents - Type of Maintenance: Updating based on new information (CPMP/ICH/283/95 adopted April 2002)

Topic Q5A, Step 4 Note for Guidance on Quality of Biotechnological Products: Viral safety Evaluation of Biotechnology Products derived from Cell Lines of Human or Animal Origin (CPMP/ICH/295/95 - adopted April 97)

Topic Q5D, Step 4 Note for Guidance on Quality of Biotechnicological Products: Derivation and Characterisation of Cell Substrates used for Production of Biotechnological/Biological Products (CPMP/ICH/294/95 adopted Sept. 97)

Topic Q5B, Step 4 Note for Guidance on Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines used for Production of r-DNA derived Protein Products (CPMP/ICH/139/95 - adopted Dec. 95)

Topic Q5C, Step 4 Note for Guidance on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (CPMP/ICH/138/95 - adopted Dec. 95)

Topic Q6A, Step 4 Note for Guidance Specifications: Test procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (CPMP/ICH/367/96 - Adopted Nov. 99)

Topic Q6B, Step 4 Note For Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (CPMP/ICH/365/96 - Adopted March 99)

Topic Q7A, Step 5 Note for Guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients (CPMP/ICH/4106/00 - released for consultation July 2000)

Topic Q8 Pharmaceutical Development

Topic Q9 Quality Risk Management