News about GMP/cGMP

05.11.2021

EU: Procedures on Inspections and Exchange of Information in new Version 18

EU: Procedures on Inspections and Exchange of Information in new Version 18

The European Commission has revised and restructured the Compilation of Community Procedures on Inspections and Exchange of Information. In addition to new content and editorial adjustments, the 295-page document has been divided into a Part I including procedural topics and a Part II containing interpretation documents and templates. The documents were last updated in 2014.


The compilation primarily serves a harmonised approach and to facilitate cooperation for inspections within the European Member States. It applies to both GMP and GDP inspections. The procedures outlined in the compilation in turn form the basis for national procedures that are part of the quality management systems of the national GMP inspectorates.

In Part I, these procedural topics have been revised in form of independent short documents:

  • Management and classification of reports of suspected quality defects in medicinal products and risk-based decision-making (new: provides more comprehensive guidance following quality risk management principles)
  • Procedure for managing rapid alerts arising from quality defects risk assessment
    (new: provides more comprehensive guidance following quality risk management principles)
  • Outline of a Procedure for Co-ordinating the Verification of the GMP Status of Manufacturers in Third Countries
  • The Issue and Update of GMP Certificates
  • A model for risk based planning for inspections of pharmaceutical manufacturers
  • Procedure for dealing with serious GMP non-compliance requiring co-ordinated measures to protect public or animal health (Procedure has been revised as a result of experience with the superseded procedure; Appendix 6: Supervisory Risk Assessment has been updated)
  • Procedure for dealing with serious GMP non-compliance information originating from third country authorities or international organisations

New in Part I:

  • Procedure for compliance management

In Part II revised interpretational documents and templates are:

  • Interpretation of the Union format for Manufacturer/Importer Authorisation
  • Interpretation of the Union format for GMP certificate
  • Interpretation of the Union format for a wholesale distribution authorisation (medicinal products for human use)
  • Union format for a GMP certificate
  • Statement of non-compliance with GMP

New in Part II:

  • Interpretation of the Union format for a wholesale distribution authorization (medicinal products for human use)

Source:
EU: CoCP on Inspections and Exchange of Informations

 


 

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