<br />
Life Sciences & Healthcare<br />
GxP - Regulatory Compliance & Risk<br />
Guideline No 22<br />
Temperature Mapping<br />
Small Fridges and Freezers<br />
Disclaimer<br />
This GxP Guideline aim is to give DHL personnel engaged in Healthcare operations with contract<br />
logistics reference to Sector Policy, Industry Regulations and International Guidelines. Although the<br />
references will cover most of the international guidelines they will not cover all and national legal<br />
requirements will always need to be checked by country Qualified Persons i.e. Sector Pharmacists and<br />
Regulatory Managers.<br />
Accordingly the document is provided upon the basis that it is disclosed without any term, condition or<br />
warrant, either expressed or implied, as to its correctness, completeness or accuracy. It is important to<br />
ensure cGMP (current Good Manufacturing Practices) are followed by using the most up to date<br />
references quoted as they are all <a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 1" href="http://viewer.zmags.com/publication/b9e0f078?page=1"> Life Sciences & Healthcare GxP - Regulatory</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 2" href="http://viewer.zmags.com/publication/b9e0f078?page=2"> Disclaimer This GxP Guideline aim is to give DHL</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 3" href="http://viewer.zmags.com/publication/b9e0f078?page=3"> Contents 1.0 PURPOSE – Compliance First! </a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 4" href="http://viewer.zmags.com/publication/b9e0f078?page=4"> This page intentionally left blank</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 5" href="http://viewer.zmags.com/publication/b9e0f078?page=5"> 1.0 PURPOSE – Compliance First! This general g</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 6" href="http://viewer.zmags.com/publication/b9e0f078?page=6"> 3.0 RESPONSIBILITY The Vice President Global R</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 7" href="http://viewer.zmags.com/publication/b9e0f078?page=7"> 4.0 DEFINITIONS BMS Building M</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 8" href="http://viewer.zmags.com/publication/b9e0f078?page=8"> 5.0 REFERENCE DOCUMENTS WHO Technical Report S</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 9" href="http://viewer.zmags.com/publication/b9e0f078?page=9"> Singapore: Health Sciences Authority – Guide MQA </a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 10" href="http://viewer.zmags.com/publication/b9e0f078?page=10"> 6.0 PROCEDURE REQUIREMENTS 6.1 Temperature M</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 11" href="http://viewer.zmags.com/publication/b9e0f078?page=11"> 6.4 Bespoke Design For a bespoke design item a </a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 12" href="http://viewer.zmags.com/publication/b9e0f078?page=12"> 6.7 Operational Qualification Objective The OQ </a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 13" href="http://viewer.zmags.com/publication/b9e0f078?page=13"> 6.11 Empty Chamber Mapping A probe location map </a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 14" href="http://viewer.zmags.com/publication/b9e0f078?page=14"> Description Key o Probes 1 to 9 locate</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 15" href="http://viewer.zmags.com/publication/b9e0f078?page=15"> 6.13 Acceptance Criteria Typical acceptance crit</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 16" href="http://viewer.zmags.com/publication/b9e0f078?page=16"> 6.16 Performance Qualification The purpose of th</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 17" href="http://viewer.zmags.com/publication/b9e0f078?page=17"> 6.18 Temperature and Load Mapping Map shows typ</a>
<a title="Guideline 22 Temperature Mapping Small Fridges and Freezers - MM Approved 16-4-14 page 18" href="http://viewer.zmags.com/publication/b9e0f078?page=18"> 6.19 Performance Qualification Report The PQ rep</a>