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Tuesday, August 30, 2016

Compilation of Community Procedures on Inspections and Exchange of Information guideline



GDP Compliance 
Active substances and medicinal products shall be distributed in accordance with good distribution practices. Member States shall enter the certificates of good distribution practices which they issue in the Union database (EudraGMDP) in accordance with Art. 111(6) of the Directive 2001/83/EC as amended.

The Community formats for the GDP Certificate for Medical Products and for active substances are published in the Compilation of Community Procedures, which can be found at the following location:

Click Here for Download /Open in pdf
Compilation of Community Procedures on Inspections and Exchange of Information

Introduction 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 procedures within it provide the basis for national procedures that form part of the national GMP inspectorates’ quality systems. These quality systems are based on a framework laid down in one of the documents of the Compilation. In July 2010 documents connected with Good Distribution Practice (GDP) inspections started to be added to the Compilation. 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, including those supervising the manufacture and import of veterinary medicinal products only. 

Once agreed, they are adopted by the European Commission and then published on its behalf by the European Medicines Agency. The Heads of Medicines Agencies have agreed to the setting up of a joint audit programme of GMP inspectorates to maintain mutual confidence in the GMP inspection systems of each member state by the other member states, and the Compilation provides criteria on which the audits are based. Member states are obliged to take account of the Compilation of Procedures by virtue of Art. 3(1) of Directive 2003/94/EC. Until such time as the corresponding GMP directive for veterinary medicinal products, Directive 91/412/EEC, is amended accordingly, GMP Inspectorates dealing exclusively with veterinary medicinal products have voluntarily agreed to abide by it, although it is recognised that the formats for inspection reports, manufacturing authorisations and GMP certificates are of a binding nature by virtue of Art. 51 of Directive 2001/82/EC, as amended.

Quality Systems Framework for GMP Inspectorates Table of contents: 
• Introduction 
• Purpose 
• Scope
 • Definitions
 • Quality Manual
 • Administrative Structure
 • Organisation and Management
 • Documentation and Change Control 
• Records
 • Inspection Procedures 
• Inspection Resources 
• Internal Audit 
• Quality Improvement and Corrective/Preventive Action 
• Complaints 
• Issue and Withdrawal of Licenses and GMP Certificates
 • Handling Suspected Quality Defects and Rapid Alert System 
• Liaison with OMCL 
• Sub-Contracting and Assessing
 • Publications


Source: EudraGMP

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