Supplement 11- Qualification of refrigerated road vehicles

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

1.2.1 Verification 

1.2.2 Qualification 

1.3 Target readership 

2. Guidance

2.1 Associated materials and equipment 

2.2 Preliminary construction validation 

2.2.1 Temperature-controlling equipment 

2.2.2 Thermal insulation 

2.2.3 Performance checks 

2.3 Field shipment test 

2.3.1 Purpose 

2.3.2 Loading 

2.3.3 Temperature probe placement 

2.3.4 Test procedure 

2.3.5 Acceptance criteria 

2.4 Temperature-control failure test 

2.4.1 Purpose 

2.4.2 Loading 

2.4.3 Temperature probe placement 

2.4.4 Test procedure 

2.4.5 Acceptance criteria 

2.5 Documentation 

2.5.1 Designation of the vehicle 

2.5.2 Results of the qualification 

2.6 Vehicle qualification failure 

2.7 Calibration 

Bibliography 

Annex 1

Placing electronic data logging monitors or temperature sensors 

Revision history 

Supplement 11- Qualification of refrigerated road vehicles: