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17 January 2011

EMA publishes two Documents on the QP Declaration concerning GMP Compliance of the API

The European Medicines Agency (EMA) has published two new draft documents for a template for the QP's declaration concerning GMP compliance of the API used as starting material and verification of its supply chain called "The QP declaration template".

1. Draft template for the Qualified Person's declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain "The QP declaration template" (EMA/CHMP/CVMP/QWP/696270/2010), consultation ends on 30 April 2011.

QP Declarations are required from each EEA finished product manufacturing site and/or from each site of importation/batch certification. However, a single declaration from one QP from one of the registered finished product or batch release sites may be sufficient, if its basis is satisfactorily described and supported by technical agreements between these sites.

The QP Declaration should be provided in support of an application for a new marketing authorisation, variation or renewal of a medicinal product(s) authorised in the Community, using EU or national procedures within the scope of the respective Directives.

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.

The attached QP declaration template provides, in a format considered suitable for submission, a basis for demonstrating compliance of the active substance manufacture with GMP requirements and that the manufacturer has relevant knowledge of the supply chain.

And

2. Draft Q&A on the template for the Qualified Person's declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain "The QP declaration template" (EMA/CHMP/CVMP/QWP/696305/2010), consultation ends on 30 April 2011.

This Q&A document addresses questions and answers on:

  • the submission of the QP declaration
  • the role of the Active Pharmaceutical Ingredient (API) manufacturing sites
  • auditing

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