WHO Supplement 8- Temperature mapping of storage areas

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 The mapping protocol 

2.2.1 Approval page and change control history 

2.2.2 Acronyms and glossary 

2.2.3 Description and rationale 

2.2.4 Scope

2.2.5 Objectives 

2.2.6 Methodology 

2.2.7 Mapping report template 

2.3 Conducting the mapping exercise 

2.4 Analysing the data and preparing the mapping report 

2.4.1 Preliminary analysis 

2.4.2 Minimum and maximum temperatures and hot and cold spots 

2.4.3 Mean temperatures 

2.4.4 Interpreting the results and making recommendations 

2.4.5 Report auditing 

2.5 Implementing the mapping report recommendations 

Bibliography

Annex 1

Test data sheets 

Revision history 

WHO Supplement 8 - Temperature mapping of storage areas: