New Compilation of Community Procedures on Inspections and Exchange of Information

The European Medicines Agency (EMA) has updated the Compilation of Community Procedures on Inspections and Exchange of Information, formerly known as the Compilation of Community Procedures on Administrative Collaboration and Harmonisation of Inspections. It is meant to be a tool for facilitating co-operation between the GMP inspectorates of the EU Member States and a means for achieving harmonisation. This is to achieve consistency in inspection standards between GMP national pharmaceutical inspectorates and thus to facilitate mutual recognition of those inspectorates.

This Update is the 12th revision, including a new procedure for inspecting wholesalers.

It is also pointed out that the pharmaceutical inspectorate should establish and maintain a defined liaison with units responsible for marketing authorisation in order to facilitate actions against marketing authorisation following an inspection, if appropriate.

Changes and updates have also been made for the rapid alert system procedures. Regarding inspection process and planning, the risk based approach is reflected in more detail. Annex 3 provides detailed guidance on the conduct of inspection of a manufacturer of active substances.

Also the procedure on "Issue and Update of GMP Certificates" and the "Procedure for Dealing with Serious GMP Non-compliance or Voiding/Suspension of CEPS Thus Requiring Coordinated Administrative Action have been revised.

EMA is responsible for maintaining and publishing the Compilation of Procedures on behalf of the European Commission. It is a collection of GMP inspection- related procedures and forms agreed by the GMP inspectorates of all the Member States and designed to facilitate administrative collaboration, harmonisation of inspections and exchange of inspection-related information. Article 3 of the GMP Directive, 2003/94/EC, requires Member States to take account of these procedures, and they are used as the basis for standard operating procedures of the quality systems established within the inspectorates themselves.

Source: EMA

You can find a detailled electronic comparison of the with the previous document in the ECA Members Area.