Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline
Table of contents
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
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Guidance for the template for the qualified person’s declaration concerning good manufacturing practice (GMP) compliance of active substance manufacture “The QP declaration template” (PDF/170.11 KB)
First published: 04/06/2014
Last updated: 04/06/2014
EMA/196292/2014 -
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Qualified Person’s declaration concerning good manufacturing practice (GMP) compliance of the active substance manufacture “The QP declaration template” (DOC/175.5 KB)
First published: 04/06/2014
Last updated: 04/06/2014
EMA/334808/2014 -
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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' (PDF/818.34 KB)
First published: 20/08/2014
Last updated: 20/08/2014
EMA/337252/2014 -
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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... (PDF/284.52 KB)
Draft: consultation closed
First published: 13/01/2011
Last updated: 20/06/2011
Consultation dates: 16/12/2010 to 30/04/2011
EMA/CHMP/CVMP/QWP/696270/2010 -
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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... (PDF/126.73 KB)
Draft: consultation closed
First published: 13/01/2011
Last updated: 20/06/2011
Consultation dates: 16/12/2010 to 30/04/2011
EMA/CHMP/CVMP/QWP/696305/2010