EMA publishes Compilation of Community Procedures on Inspections and Exchange of Information

In agreement with the European Commission the European Medicines Agency (EMA) has published a Compilation of Community Procedures on Inspections and Exchange of Information. Although primarily addressed to inspectorates, it is also an interesting document for those being inspected.

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, is a tool for facilitating co-operation between the GMP inspectorates of the Member States and a means of achieving harmonisation. The contents of the Compilation of Procedures are constantly updated developed and agreed, under the co-ordination of the European Medicines Agency, by representatives of the GMP Inspectorates of each member state.

In the latest version, the part 'Exchange of Information on Manufacturers and Manufacturing or Wholesale Distribution Authorisations Between Competent Authorities in the European Economic Area' has been deleted.

The compilation now contains the following parts:

- Quality Systems Framework for GMP Inspectorates (April 2008)

- Procedures Related to Rapid Alerts:

  • Handling of Reports of Suspected Quality Defects in Medicinal Products (August 2010)
  • Procedure for Handling Rapid Alerts Arising From Quality Defects (January 2010)

- Procedures Related to GMP Inspections

  • Conduct of Inspections of Pharmaceutical Manufacturers or Importers (January 2010)
  • Outline of a Procedure for Co-ordinating the Verification of the GMP Status of Manufacturers in Third Countries (July 2005)
  • Guideline on Training and Qualifications of GMP Inspectors (December 2008)
  • Guidance on the Occasions When It Is Appropriate for Competent Authorities to Conduct Inspections at the Premises of Manufacturers of Active Substances Used as Starting Materials (October 2005)
  • The Issue and Update of GMP Certificates (September 2007)
  • A Model for Risk Based Planning for Inspections of Pharmaceutical Manufacturers (April 2008)
  • Procedure for Dealing With Serious GMP Non-compliance or Voiding/Suspension of CEPS thus Requiring Coordinated Administrative Action (January 2010)

- Procedures Related to Inspections of Wholesale Distributors

  • Guideline on Training and Qualification of Inspectors Performing Inspections of Wholesale Distributors (April 2011)

- Forms Used by Regulators

  • GMP Inspection Report - Community Format (August 2010)
  • Community Basic Format for Manufacturer's Authorisation (December 2006)
  • Community Format for a GMP Certificate (December 2006)

- Procedures Related to Centralised Procedures

  • Co-ordinating GMP Inspections for Centrally Authorised Products

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