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
Introduction
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
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