Compilation of Union Procedures on Inspections and Exchange of Information

On 20 April 2022 the EMA published the compilation of union procedures on inspections and exchange of information.

The Compilation of Union Procedures on Inspections and Exchange of Information (hereafter referred to as ‘Compilation’), formerly known as the Compilation of Community Procedures on Administrative Collaboration and Harmonization of Inspections, is a tool for facilitating co-operation between the GMP and GDP inspectorates of the Member States and a means of achieving harmonization. The procedures within it provide the basis for national procedures that form part of the national GMP inspectorates’ quality systems. These quality systems are based on a framework laid down in one of the documents of the Compilation. In July 2010 documents connected with Good Distribution Practice (GDP) inspections started to be added to the Compilation.

The Compilation has two parts; procedures within the Part I and other documents (e.g. interpretation documents and forms used by regulators) within the Part II.

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