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ECA/PQG Guides

Cover of the Good Distribution Practice for Active Substances Guidance
Cover if the GDP Guidance on Interpretation and Implementation

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The European GDP Association

On 7 March 2013, the EU Good Distribution Practices (GDP) Guideline was published in the Official Journal of the European Union. Six months later, on September 8, 2013, the Good Distribution Practice Guideline came into operation.

The new GDP Guide which replaces the 1994 GDP Guideline 94/C 63/03 defines a number of new provisions. The requirements will apply not only to wholesalers and manufacturers of medicinal products; it also incorporates the specific requirements for brokers dealing with pharmaceutical products. This is why the ECA Foundation Board has established the GDP Group.

The risk of counterfeit medicine possibly coming into the legal supply chain as well as adulteration, cross contamination and any other negative impact on the quality and integrity of the medicinal product have to be avoided. For that reason, the GDP Guideline is intended to ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products. But many practical questions still need to be answered, e.g. regarding
  • how to set up an appropriate Quality Management System
  • what detailed requirements exist for premises and equipment
  • how to proceed with outsourced activities
  • what is needed to safeguard transportation

Not only industry but also regulatory authorities will have to use the GDP Guideline and will have to implement GDP inspection procedures to comply with this standard. However, as many requirements in the GDP Guideline are not clear and require interpretation, it is the objective of the ECA Foundation’s GDP Working Group to support all stakeholders involved in Good Distribution Practices by providing information on the interpretation of the Guide.

In August 2016, the European GDP Group was reorganised to become the European GDP Association. It is the goal of the Association to represent Responsible Persons for GDP, Logistic Managers and other individuals involved in a secure pharma supply chain.

Board of Directors

The following colleagues form the Board of the GDP Working Group:

Dr Afshin Hosseiny
Qualified Person, UK (Chair)
Prabjeet Dulai
GDP & Quality Matters, UK (Director of Regulatory Affairs and Communication)
Dr Martin Egger
Pharmaserv, Germany
Dr Christian Grothe-Westrick
B. Braun Avitum
Sue Mann
Sue Mann Consultancy, UK
Dr Laura Ribeiro
OCP Portugal, Portugal
Saddam Huq
Emil Schwan
RegSmart Life Science, Sweden

Authority Advisory Board

The Authority Advisory Board is not part of the legal structure. The Advisory Board Members support the GDP Working Group on a case by case decision and not for all of its activities. The following Board Members of the ECA Foundation Board support the GDP Working Group:

Dr Daniel Müller 
GMP Inspectorate Tuebingen, Germany

Please find here all Members of the Authority Board of the ECA Foundation.


From 2018, the European GDP Association will publish activity overviews twice a year:

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