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