Warning: Creating default object from empty value in /home4/sspccco/public_html/pharmafacts.com/plugins/system/J2top.php on line 78
The Role and Responsibility of the Sponsor in the Application of the Principles of GLP - PharmaFacts
gototopgototop
If you don't find what you're looking for, please let us know.

Warning: Creating default object from empty value in /home4/sspccco/public_html/pharmafacts.com/plugins/system/modulesanywhere.php on line 159

The Role and Responsibility of the Sponsor in the Application of the Principles of GLP

Guidances - OECD Guidances

Although the revised Principles of Good Laboratory Practice only explicitly assign a few responsibilities to the sponsor of a study, the sponsor has other implicit responsibilities. These arise from the fact that the sponsor is often the party who initiates one or more studies and directly submits the
results thereof to regulatory authorities. The sponsor must therefore assume an active role in confirming that all non-clinical health and environmental safety studies were conducted in compliance with GLP. Sponsors cannot rely solely on the assurances of test facilities they may have contracted to arrange or perform such studies. The guidance given below attempts to outline both the explicit and implicit responsibilities of a sponsor necessary to fulfil his obligations.

ROLE_AND_RESPONSIBILITIES_OF_THE_SPONSOR.pdf