EU: Important Document for Inspections revised

The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents. The most fundamental change is the division into two parts. The first part covers and describes the various processes in short sub-documents, the second part contains interpretative documents and templates.

The Compilation of Union Procedures on Inspections and Exchange of Information is a compilation of EU procedures for inspections and exchange of information, with the aim of facilitating cooperation between the GMP and GDP inspections of the member states and harmonising procedures. National procedures should then be derived from this as part of the quality assurance systems of the national GMP inspectorates. The document is maintained by representatives of the national GMP inspectorates under the coordination of the European Medicines Agency (EMA).

Revision of Part 1 and Part 2

The following documents in Part 1 have been revised:

  • Management and classification of reports of suspected quality defects in medicinal products and risk-based decision-making (revised in order to provide more comprehensive guidance following quality risk management principles).
  • Management of rapid alerts arising from quality defects risk (revised in order to provide 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 (Updated to include section on reassessment of GMP certificates and modification of the section on the distant assessment procedure)
  • The issue and update of GMP certificates (Minor update primarily to align with experience)
  • A Model for Risk Based Planning for Inspections of Pharmaceutical Manufacturers (Minor editorial changes)
  • 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co-ordinated measures to protect public or animal health (Procedure has been revised as a result of experience with the superseded procedure, Appendix 6: Supervisory Risk Assessment has been updated)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 (Minor updates to reflect current practice)
  • Procedure for compliance management new document; describing the use of inspection and non-inspection monitoring measures to proactively manage manufacturing, importation and wholesale authorisation holders and manufacturers of active substances  demonstrating deficiencies in GMP/GDP compliance or other risk indicators, when it is considered that  routine inspection may not to be effective in achieving compliance improvements within a satisfactory  time period.

In Part 2, the following documents have been revised:

  • Interpretation of the Union format for Manufacturer/ Importer (further interpretation on the biological testing)
  • Interpretation of the Union format for GMP certificate (updated to reflect current practice)
  • Interpretation of the Union format for a wholesale distribution authorisation (medicinal products for human use) (new procedure)
  • Union Format for a GMP Certificate (updated to reflect current practice)
  • Statement of non-compliance with GMP (updated to reflect current practice)

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