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)
B. Braun Avitum
Sue Mann Consultancy, UK
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:
Finnish Medicines Agency FIMEA
Medical Products Agency (MPA), Sweden
Please find here
all Members of the Authority Board of the ECA Foundation.
In July 2013, the Working Group signed a Joint Venture Agreement with the Pharmaceutical Quality Group (PQG) of the Chartered Quality Institute. Both groups intend to develop a Guideline for interpretation of the EU GDP Guideline.
- a gap analysis/audit tool document for each chapter
- assistance to clarify the requirements and provide information about how to implement them in each section of the guideline
Now, all the Chapters have been finalized and can be downloaded from the Members Area.
It is the objective of the European GDP Association to support:
- Exchange/share information relevant to GDP environment
- Sharing best practices
- Harmonisation of the GDP regulatory requirements’ implementation across EU
- Review and comment on the regulatory publications
- Influence regulatory requirements to develop workable GDP Guidelines
- Develop document to help implement the GDP Guidelines