WHO TRS (Technical Report Series) 992, 2015 Annex 5

Sathyanarayana M.Sc.
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WHO TRS (Technical Report Series) 992, 2015 Annex 5

Technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products

(WHO Technical Report Series, No. 961, 2011), Annex 9

1. The technical supplement series:

This series of technical supplements has been written to amplify the recommendations given in Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (WHO Technical Report Series, No. 961, 2011, Annex 9). This document sets out the principal requirements for the safe storage and distribution of time- and temperature sensitive pharmaceutical products (TTSPPs).

The introduction to the guidance documents states that: “... supplementary materials will be developed to show how the requirements can practicably be achieved, particularly in resource constrained settings.” The technical supplements, which make up this volume, are intended to provide this additional material; each one is linked back to a specific clause or clauses in the parent document. All 16 documents are written in a standard format and each contains a reference section with hyperlinks to relevant supporting materials. Most of these materials are available free online. References to print publications are minimized to avoid the difficulties associated with purchasing books and journals.

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Table of Contents

1. The technical supplement series

Supplement 1: Selecting sites for storage facilities 

Supplement 2: Design and procurement of storage facilities 

Supplement 3: Estimating the capacity of storage facilities 

Supplement 4: Building security and fire protection 

Supplement 5: Maintenance of storage facilities 

Supplement 6: Temperature and humidity monitoring systems for fixed storage areas 

Supplement 7: Qualification of temperature-controlled storage areas 

Supplement 8: Temperature mapping of storage areas 

Supplement 9: Maintenance of refrigeration equipment 

Supplement 10: Checking the accuracy of temperature control and monitoring devices 

Supplement 11: Qualification of refrigerated road vehicles

Supplement 12: Temperature-controlled transport operations by road and by air 

Supplement 13: Qualification of shipping containers 

Supplement 14: Transport route profiling qualification 

Supplement 15: Temperature and humidity monitoring systems for transport operations 

Supplement 16: Environmental management of refrigeration equipment



WHO TRS (Technical Report Series) 992, 2015 Annex 5:
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