EMEA and European
Commission Publish Document to describe the Issue and Update of GMP
Certificates
The European Medicines Agency EMEA and EU Commission's DG Enterprise
and Industry Directorate have developed a document which describes the
issue and update of GMP Certificates. The paper is part of the
Compilation of Community Procedures on Inspections and Exchange of
Information. The document is intended to give interpretation on aspects
of responsibilities of the issue, renewal and update of GMP
certificates. The issue of GMP certificates following an inspection of a
manufacturer of IMPs is not defined. However, Member States may choose to
do so.
GMP certificates are for the purpose of confirming to a manufacturer
(whether for active substances or medicinal products) the overall
conclusion of an inspection with respect to compliance with GMP. In some
cases, particularly outside of the EEA, they may be used by applicants
to support regulatory submissions. GMP certificates issued by EEA
authorities are recognised within the framework of WHO and fulfil
obligations under the Mutual Recognition Agreements. However, within the
EEA they do not replace confirmation of the holding of a manufacturing
authorisation.
For active substances, the supporting document in regulatory
submissions is the declaration by the Qualified Person of the
manufacturing authorisation holder that uses the active substance as a
starting material.
Author:
Wolfgang Schmitt
On behalf of the European QP Association
