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

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


Kılavuzlar ve Diğer Dokümanlar

“The Complete Stability Testing”

1.         Guidelines for Stability Testing


1.1         Stability Testing of New Drug Substances and Products, ICH Q1A(R2)    

1.2         Photostability Testing of New Substances and Products, ICH Q1B

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

1.3.1          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 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 Q3A(R)            

1.10      Impurities in New Drug Products, ICH Q3B( R)                                                  

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 Authorization in the EU, CPMP/QWP/576/9


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


4.         Documents


4.1       Testing Specification for Release and Stability Testing

4.2       Validation Report

4.3       Stability Report: Stability Profile of Drug Substance

4.4       Stability Report for Clinical Samples

4.4.1     Phase I

4.4.2     Phase II

4.4.3     Phase III

4.5       Stability Report: Stability Profile of Drug Product

4.6       Stability Report Drug Substance for Registration

4.7       Stability Report Drug Product for Registration