The Complete Stability Testing :
Strategies, Requirements, Basic Principles, Performance, Documents

Istanbul 15.-16. January 2004 Dr. Wolfgang Grimm



Seminer Sunumlarý

Content of the paper part of the workshop




1.         Requirements Guidelines and comments for its application


1.1        Stability Testing of New Drug Substances and Products, ICH Q1AR               

1.2        Photostability Testing of New Substances and Products, ICH Q1B

1.3        Stability Testing, Requirements for New Dosage Forms, ICH Q1C 

1.4       Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, ICH Q1D

1.5        Evaluation of stability Data ICH Q1E                                           

1.6        Stability Data Package for Registration Applications in Climatic Zones III and IV, ICH Q1F

1.7        Validation of Analytical Methods Definitions and Terminology, ICH Q2A

1.8        Validation of Analytical Procedures Methodology, ICH Q2B

1.9        Impurities in New Drug Substances, ICH Q3AR   

1.10      Impurities in New Drug Products, ICH Q3BR        

1.11      Impurities Residual Solvents, ICH Q3C                

1.12                  Specifications, Test Procedure sand Acceptance Criteria for New Drug Substances and New Drug Products; Chemical Substances, ICH Q6A          

1.13                  Common Technical Document for Registration of Pharmaceuticals for human use, Organization CTD, ICH M 4, Quality, M4Q

1.14      Stability Testing for a Type II Variation to the Marketing Authorisation in  the EU

1.15      Stability Testing of Existing Active Substances and Related Finished Products CPMP/QMP/122/02 (Revision of CPMP/QWP/556/96)


2.         Basic Principles of Stability Testing


2.1        Introduction      

2.2        Test Attributes                                                  

2.3        Analytical Procedures                           

2.4        Acceptance Criteria and Specifications               

2.4.3     Testing Specifications                                       

2.9        Container Closure System                                             

2.10      Evaluation, Application of Reaction Kinetics        


3.         Performance


3.1        Stress- and accelerated testing with the drug substance              

3.2        Preformulation and formulation finding                                                     

3.3                    Stress and accelerated testing with selected formulations, Clinical trial batches, selection of container closure systems, up-scaling, registration batches

3.4                    Accelerated and Long-Term Testing with registration batches up to Registration Application

3.5        0n-going Stability Testing           

3.6        Follow-up Stability Testing, Variations and Changes