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Thursday, January 19, 2017

Handling of Reports of Suspected Quality Defects in Medicinal Products

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GDP Compliance
 : EMA
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:

The EudraGMDP Database contains GMP and GDP Compliance and Non-Compliance reports. So far a lot of GMP information has been published by the EU authorities but less about GDP compliance. Every EU Member State Inspectorate is asked to publish their GMP and GDP Inspection results. This will allow other authorities and industry to check the compliance status of certain companies.

A number of EU authorities have not published their GDP data information yet. However, progress can be seen also with regard to GDP compliance certificates and GDP non-compliance reports. From January 2016 until today six GDP non-compliance reports have been published. The Czech authority published three, the Danish authority two and a German inspectorate one GDP non-compliance report.

The current reports are not very detailed. However, some information can be found. For instance, for the company Ya Medicare in Winsen Germany the inspectors state: "The company has in general failed to comply with good distribution practice as they did not use the described quality system. The company has written procedures but was not able to show an adequate documentation for acting according to the procedures. Further the company does not have relevant documentation for storage and transport under correct temperature, a system for ensuring that they only obtain their supplies of medicine from companies with a valid WDA/MIA or a system for ensuring that they only supply medicines to companies with a valid WDA or a valid license to supply medicinal products to the public." The information provided in the report is very helpful in order to understand the nature of the non-compliance.



1. Introduction 
1.1 One of the main purposes of the GMP/GDP Inspectors Working Group is to establish and maintain a system for mutual recognition of national inspections in respect of the manufacture and, where relevant, wholesale distribution of medicinal products and for the administrative collaboration between Member States (MS) of the European Economic Area (EEA). The general requirements for national pharmaceutical inspectorates are to fulfil the requirements of national legislation and of the relevant European Directives for EEA countries. Specific obligations of inspections as contained in national law and if any European Directives must be included in the national Inspectorate’s quality systems.

 1.2 This document outlines the quality system requirements for GMP pharmaceutical inspectorates. It is intended that each GMP pharmaceutical inspectorate uses the document as the basis for developing and implementing its quality system and for preparing the quality manual. In addition to providing a basis for self-assessment and a reference document for use by external assessors, establishing and maintaining an effective quality system will generate confidence within and between GMP national pharmaceutical inspectorates in the assessment of compliance with good manufacturing practice and/or good wholesale distribution practice.

1.3 National GMP pharmaceutical inspectorates, the European Commission (EC), the European Medicines Agency (EMEA) and the pharmaceutical Inspection Cooperation Scheme – (PIC/S) should co-operate with one another in exchanging experiences in the maintenance and operation of quality systems and in the further development of this document. 

1.4 Only on voluntary basis, this document could be useful for (other) inspectorates assessing compliance with GXP or for the inspection of pharmacies.

 1.5 In preparing this text, the working group was advised by: EN ISO/IEC 17020:2005 General criteria for the operation of various types of bodies performing inspections; EN ISO/IEC 17023:2006 General requirements for bodies operating assessment and certification/ registration of quality system; ISO 9001-2000 Quality management systems-Requirements;

 ISO 9004-2000 Quality management systems: guidelines for performance improvements; 

ISO 19011 : 2002 Guidelines for quality and/or environmental managerial systems auditing; 

PI 002-1 : 2000 Recommendations on quality system requirements for pharmaceutical inspectorates; Compilation of Community Procedures on Inspections and Exchange of Information 

EMA/572454/2014 Rev 17 Page 7/253 May 2001 Revised Compilation of Community procedures on administrative collaboration and harmonisation of inspections; 1998 Proceedings of the PIC-PIC/S seminar on quality systems for pharmaceutical inspectorates.


Handling of Reports of Suspected Quality Defects in Medicinal Products
Procedure for Handling Rapid Alerts Arising from Quality Defects

Download:  Full guideline

Quality Systems Framework for GMP Inspectorates 
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