31.05.2017 | LOGFILE Feature 21/2017

An excerpt from the GMP Series Quality Agreement

Quality Agreement – A Sample Document

by Dr. Christine Oechslein

We have prepared for you page 1 and 3 of the document. Please click on the following link to read the excerpt.


As the pharmaceutical industry increasingly outsources activities to third parties, Quality Agreements are becoming more and more important.

Failing to determine goals or responsibilities, can leave both partners vulnerable.

Using our sample document "Quality Agreement" help is on hand:

It defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.