<br />
Life Sciences & Healthcare<br />
GxP - Regulatory Compliance & Risk<br />
Guideline No 15<br />
Blood and Blood Products<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 being continually amended.<br<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 1" href="http://viewer.zmags.com/publication/206d5227?page=1"> Life Sciences & Healthcare GxP - Regulatory </a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 2" href="http://viewer.zmags.com/publication/206d5227?page=2"> Disclaimer This GxP Guideline aim is to give DHL</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 3" href="http://viewer.zmags.com/publication/206d5227?page=3"> Contents PRINCIPLE </a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 4" href="http://viewer.zmags.com/publication/206d5227?page=4"> This page intentionally left blank</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 5" href="http://viewer.zmags.com/publication/206d5227?page=5"> PRINCIPLE Medicinal products derived from human </a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 6" href="http://viewer.zmags.com/publication/206d5227?page=6"> inadvertently frozen then, depending on the tempe</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 7" href="http://viewer.zmags.com/publication/206d5227?page=7"> 3.0 RESPONSIBILITY The Vice President of Globa</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 8" href="http://viewer.zmags.com/publication/206d5227?page=8"> 4.0 DEFINITIONS AABB Ame</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 9" href="http://viewer.zmags.com/publication/206d5227?page=9"> GLOSSARY OF BLOOD PRODUCTS Aetiology (UK) Etiolo</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 10" href="http://viewer.zmags.com/publication/206d5227?page=10"> haemolysins, immune reactions like specific compl</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 11" href="http://viewer.zmags.com/publication/206d5227?page=11"> White Blood Cells (leucocytes or leukocytes) Bloo</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 12" href="http://viewer.zmags.com/publication/206d5227?page=12"> 5.0 REFERENCE DOCUMENTS DHL Yellow Book GxP Gu</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 13" href="http://viewer.zmags.com/publication/206d5227?page=13"> The Handbook of Transfusion Medicine Third Editio</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 14" href="http://viewer.zmags.com/publication/206d5227?page=14"> 6.0 PROCEDURE REQUIREMENTS 6.1 Quality Managem</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 15" href="http://viewer.zmags.com/publication/206d5227?page=15"> 6.2 Personnel and Organisation Personnel in blood</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 16" href="http://viewer.zmags.com/publication/206d5227?page=16"> and an archive of superseded documents establishe</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 17" href="http://viewer.zmags.com/publication/206d5227?page=17"> Where computerised systems are used, hardware and</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 18" href="http://viewer.zmags.com/publication/206d5227?page=18"> failures so that error can be minimised or elimin</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 19" href="http://viewer.zmags.com/publication/206d5227?page=19"> are not known to have been maintained with</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 20" href="http://viewer.zmags.com/publication/206d5227?page=20"> Biohazards Biohazards are components from donatio</a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 21" href="http://viewer.zmags.com/publication/206d5227?page=21"> • The name of the recipient is entered on the </a>
<a title="Guideline 15 - Blood and Blood Products Reviewed and Approved by MM 2-5-13 page 22" href="http://viewer.zmags.com/publication/206d5227?page=22"> transport temperature within the 2°C to 10°C rang</a>