WHO Supplement 13- Qualification of shipping containers

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 The three stages of qualification 

2.1.1 Design qualification 

2.1.2 Operational qualification 

2.1.3 Performance qualification 

2.1.4 Re-qualification of reusable container systems 

2.2 Associated materials and equipment 

2.2.1 Test equipment for design and operational qualifications 

2.2.2 Test equipment for performance qualification 

2.3 The performance qualification test protocol 

2.3.1 Protocol title 

2.3.2 Protocol approvals 

2.3.3 Introduction 

2.3.4 Purpose 

2.3.5 Scope 

2.3.6 Acceptance criteria 

2.3.7 Responsibilities 

2.3.8 Test procedure 

2.3.9 Data analysis 

2.4 The performance qualification test 

2.5 The performance qualification report 

Bibliography 

Revision history 

WHO Supplement 13- Qualification of shipping containers: