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

Current effective version

Guidance for the template for the qualified person’s declaration concerning good manufacturing practice (GMP) compliance of active substance manufacture “The QP declaration template”

Reference Number: EMA/196292/2014

Document history

Guidance for the template for the qualified person’s declaration concerning good manufacturing practice (GMP) compliance of active substance manufacture “The QP declaration template”

Reference Number: EMA/196292/2014

Qualified Person’s declaration concerning good manufacturing practice (GMP) compliance of the active substance manufacture “The QP declaration template”

Reference Number: EMA/334808/2014

Draft template for the qualified person’s declaration concerning good-manufacturing-practice compliance of the active substance used as starting material and verification of its supply chain 'the QP declaration template'

Reference Number: EMA/337252/2014

Draft template for the Qualified Person’s (QP's) declaration concerning good-manufacturing-practice compliance of the active substance used as starting material and verification of its supply chain “the QP declaration te...

Consultation dates: 16/12/2010 to 30/04/2011Draft: consultation closedReference Number: EMA/CHMP/CVMP/QWP/696270/2010Summary:

The objective of this Qualified Person (QP) Declaration Template is to emphasise the importance of providing a comprehensive declaration, to harmonise the format for the declaration, to forestall questions during assessment, and to enhance the efficiency of the regulatory process.

Draft questions and answers on the template for the Qualified Person’s (QP's) declaration concerning good-manufacturing-practice compliance of the active substance used as starting material and verification of its supply...

Consultation dates: 16/12/2010 to 30/04/2011Draft: consultation closedReference Number: EMA/CHMP/CVMP/QWP/696305/2010