WHO TRS 970, 2012 Annex 3

 WHO Guidelines For Pharmaceutical Development of Multi source (generic) Finished Pharmaceutical Products – points to consider  

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TABLE CONTENTS

1. INTRODUCTION 

1.1 General Principles 

1.2 Scope 

2. PREDEVELOPMENT ACTIVITIES 

2.1 Desk Research 

   2.1.1 Quality Risk Management 

2.2 Additional Considerations 

   2.2.1 Selection and Characterization Of Comparator Finished Pharmaceutical Product(s) 

   2.2.2 Benchmarking For Formulation Experiments and Stability Studies 

   2.2.3 Formulation Selection Experiments 

   2.2.4 Bioequivalence and Dissolution Studies

 

3. PHARMACEUTICAL DEVELOPMENT 

3.1 Components Of The Finished Pharmaceutical Product 

   3.1.1 Active Pharmaceutical Ingredient 

   3.1.2 Excipients 

3.2 Finished Pharmaceutical Product 

   3.2.1 Formulation Development 

   3.2.2 Overages 

   3.2.3 Physicochemical and Biological Properties 

3.3 Manufacturing Process Development 

3.4 Container-Closure System 

3.5 Microbiological Attributes 

3.6 Compatibility 

4. GLOSSARY 

REFERENCES 

APPENDIX 1 

   Examples Of Presenting Quality Attributes Of Active Pharmaceutical Ingredients 

APPENDIX 2 

   Information On Development Batches 

Pharmaceutical Development of Multi source (generic) Finished Pharmaceutical Products – points to consider, (WHO Technical Report Series 970, 2012 Annex 3)