WHO Supplement 14- Transport Route Profiling Qualification

WHO Supplement 14- Transport Route Profiling Qualification

Technical Supplement to WHO Technical Report Series No. 961, 2011 

Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products

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TABLE OF CONTENTS

Abbreviations 

Acknowledgements 

Glossary 

1. Introduction

1.1 Requirements 

1.2 Objectives 

1.3 Target readership 

2. Guidance 

2.1 Associated materials and equipment 

2.2 Study protocol 

2.3 Carrying out the study 

2.4 Data retrieval 

2.5 Understanding temperature exposure: the degree-hour concept 

2.6 Organizing, analysing and using the data 

2.6.1 Method A for designing and testing packaging solutions 

2.6.2 Method B for passive containers with known performance characteristics 

Bibliography 

Annex 1

Method B examples 

A1.1 Using the data 
A1.2. The warm climate case 
A1.2.1 Step 1: organize and analyse the route profile data 
A1.2.2 Step 2: assess container suitability 
A1.3 The cold climate case 
A1.3.1 Step 1: organize and analyse the route profile data 

A1.3.2 Step 2: assess container suitability 

Revision history 

WHO Supplement 14- Transport Route Profiling Qualification