Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline

This guideline applies to human and veterinary medicines.

This document provides guidance on the data to be included in a qualified person (QP) declaration and a template to harmonize its format. QP declaration is required for marketing authorisations to confirm that the active substance has been manufactured in accordance with good manufacturing practice for medicinal products.

Keywords: Qualified person's (QP) declaration, good manufacturing practice (GMP​​​​​​), compliance