EMA updates "Compilation of Community Procedures on Inspections and Exchange of Information"

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:

  • Rapid alerts because of quality defects in medicinal products (four procedures) 
  • GMP inspections at the premises of manufacturers of medicinal products and active substances (eight procedures) 
  • GDP inspections (one procedure) 
  • Inspections of centrally authorised medicinal products (one procedure)

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:

  • Supply chains for medicinal products and active substances must comply with the principles of Good Distribution Practice. 
  • Distributors have the obligation to notify. 
  • Imported active substances from third countries must be accompanied by a GMP conformity certificate from the competent authority of the exporting country.  
  • The authorities of the exporting countries must notify (the authority of the importing country) in the case of non-compliance with GMP.

Hence, the following new documents were added to the "Compilation of Procedures":

  • Procedure for Dealing with Serious GMP Non-Compliance Information Originating from Third-Country Authorities or International Organisations

The following new forms were developed concerning this topic:

  • Wholesale Distribution Authorisation 
  • Good Distribution Practice Certificate for Wholesalers 
  • Good Distribution Practice Certificate for Distributors of Active Substances 
  • Statement of Non-Compliance with Good Distribution Practice for Medicinal Products 
  • Statement of Non-Compliance with Good Distribution Practice for the Distribution of Active Substances 
  • Registration of Manufacturer, Importer or Distributor of Active Substances

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".

Author:
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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