The "Compilation of Community Procedures on Inspections and Exchange of Information" consists of a number of documents that provide the basis of co-operation between the GMP inspectorates of the Member States. The first part of this collection of documents describes a framework of a quality system each national GDP inspectorate should have. This part is followed by a compilation of 14 procedures related to the following topics:
The compilation is supplemented by ten forms to be used by GMP inspectors according to the relevant procedures. The EMA regularly maintains this compilation. In the light of the requirements of the new Directive on the fight against falsified medicinal products (2011/62/EU), an update was needed. The following is a brief summary of the Directive's requirements:
Hence, the following new documents were added to the "Compilation of Procedures":
The following new forms were developed concerning this topic:
Although the procedures in the "compilation" are intended to be used exclusively by inspectors, manufacturers of medicinal products and active substances can nevertheless benefit from the procedures as regards the content - especially in the course of preparing for a GMP inspection by the authorities.
For further information please see the updated "Compilation of Community Procedures on Inspections and Exchange of Information".
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)