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

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This guideline applies to human and veterinary medicines.

Current effective versionTemplate guidance
Template
Reference numberEMA/196292/2014
Published05/06/2014
Effective from05/06/2014
KeywordsQualified person's (QP) declaration, good manufacturing practice (GMP), compliance
DescriptionThis 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.


Document history

First version
Current version

Template guidance


Template


Overview of comments


Draft template


Draft questions and answers

In operation: 05/06/2014–present


Published: 05/06/2014


Published: 20/08/2014


Published: 13/01/2014


Published: 13/01/2014


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