Compilation of Union procedures on inspections and exchange of information

The European Medicines Agency (EMA) maintains a compilation of inspection-related procedures and templates used by the good manufacturing practice (GMP) and good distribution practice (GDP) inspectorates in the European Union (EU) and European Economic Area (EEA).

These procedures and templates cover the basis for national procedures that form part of the national inspectorates' quality system.

This facilitates cooperation between EU Member States and supports harmonisation and exchange of inspection-related information.

The compilation comprises the following:

• Procedures to support inspections of manufacturers and wholesale distributors
• Templates used in the common EudraGMDP database and guidance on how to use them

In August 2024, Compilation of Union Procedures on Inspections and Exchange of Information (CoUP) was restructured from one document into separate documents for every procedure/template. From August 2024 onwards, updates for every procedure/template are recorded in these individual documents.

Procedures

Introduction to the Compilation of Union procedures on inspections and exchange of information

Quality systems framework for Good Manufacturing Practice (GMP) inspectorates

Management and classification of reports of suspected quality defects in medicinal products and risk-based decision-making

Management of rapid alerts arising from quality defects risk assessment

Conduct of inspections of pharmaceutical manufacturers or importers

Outline of a procedure for co-ordinating the verification of the GMP status of manufacturers in third countries

Guideline on training and qualifications of good manufacturing practice (GMP) inspectors

Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipients used as starting materials

The issue and update of good manufacturing practice (GMP) certificates

A model for risk based planning for inspections of pharmaceutical manufacturers

Procedure for dealing with serious good manufacturing practice (GMP) non-compliance information originating from third country authorities or international organisations

Procedure for dealing with serious good manufacturing practice (GMP) non-compliance requiring co-ordinated measures to protect public or animal health

Guideline on training and qualification of inspectors performing inspections of wholesale distributors

Good distribution practice (GDP) inspection procedure

The issue and update of good distribution practice (GDP) certificates

Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products

Legal effective date: 01/01/2025

Procedure for compliance management

EU/EEA programme for maintenance of equivalence in supervision of good manufacturing practice compliance of pharmaceutical companies

Interpretation documents and templates

Interpretation of the Union format for manufacturer / importer authorisation

Interpretation of the Union format for good manufacturing practice (GMP) certificate

Interpretation of the Union format for a wholesale distribution authorisation

Good manufacturing practice (GMP) inspection report - Union format

Union format for manufacturer’s authorisation

Union format for a good manufacturing practice (GMP) certificate

Statement of non-compliance with good manufacturing practice (GMP)

Notification of serious good manufacturing practice (GMP) non-compliance information originating from third country authorities or international organisations

Union format for a good distribution practice (GDP) certificate

Union format for a good distribution practice (GDP) certificate for active substances to be used as starting materials in medicinal products

Good distribution practice (GDP) inspection report – Union format

Union format for a wholesale distribution authorisation

Statement of non-compliance with good distribution practice

Statement of non-compliance with good distribution practice of a distributor of active substances for use as starting materials in medicinal products

Request form for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA

Union format for registration of manufacturer, importer or distributor of active substance

History of changes to the compilation of procedures