The Responsible Person for Good Distribution Practice (GDP)

The Responsible Person for Good Distribution Practice (GDP)

Hamburg, Germany

Course No 21053

This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager". Learn more.



ECA-Member*: EUR 1690,--
Non ECA Member*: EUR 1890,--
EU/GMP Inspectorates*: EUR 945,--
APIC Member Discount*: EUR 1790,--
GDP Association Member Discount*: EUR 1690,--
QP Member Discount*: EUR 1690,--

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Alfred Hunt, Hunt Pharma Solutions
Dr Daniel Müller, GMP/GDP Inspector
Jonathan Riley, Takeda UK
Dr Torsten Schmidt-Bader, moveproTec


The EU-GDP Guidelines require that wholesale distributors have to appoint a Responsible Person (RP) for GDP. There has been a lot of discussion about the duties of the RP. Therefore, the ECA Foundation’s GDP Working Group has developed this training course. In this course, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed.


In 2013 the “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” were published. The Guidelines were revised to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union.

In Chapter 2 “Personnel”, tasks and responsibilities of the RP are defined. RPs should fulfil their responsibilities personally and should be continuously contactable. The RP should have appropriate competence and experience as well as knowledge of and training in GDP. He or she may delegate duties but not responsibilities. The RP should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.

Target Group

The Training Course is of particular interest to Responsible Persons but also management and quality personnel from pharmaceutical companies, wholesalers, distributors and service providers involved in distribution of medicinal products.

Roadmap to Good Distribution Practice

All participants receive a Roadmap to Good Distribution Practice containing:
  • An overview of the designated Responsibilities for Senior Management, Responsible Person and Authority
  • Checklist for the implementation of GDP principles


The EU-GDP Guidelines
  • The counterfeit directive and the introduction of the EU GDP Guidelines
  • GDP requirements for the pharmaceutical supply chain
  • Regulatory expectations for implementation
Roles and Responsibilities of the Responsible Person
  • Qualifications requirements for RPs
  • Duties and delegation
  • How to discharge your duties
Experiences from GMDP Inspections
  • Inspections of the competent authorities
  • Typical GDP inspection findings
Controlled Temperature Distribution
  • How to manage cold chain products
  • How to manage 15 – 25 °C requirements
  • Air freight, sea freight, road transport and the last mile
GDP Audits
  • How to plan the Audit
  • Approach to GDP Audits
  • Reporting deficiencies
  • Examples of recent audit findings
Management of Export and Import
  • Annex 21: Importation of medicinal products
  • What does batch release mean?
  • Export and import to and from UK
Validation of Computerized Systems under GDP Regulation
  • Validation requirements – regulatory overview
  • GAMP oriented validation approach of GDP critical systems
Case Study: Validation of a new Warehouse and Material Management System
  • Wholesaler in Germany
Workshop: Deviation Management
During this workshop participants will learn and discuss how to ensure that the deviation System is being correctly used and implemented.

Roles and Responsibilities of an RP and a QP
  • Responsible Person vs. Qualified Person
  • GDP vs. GMP
  • Product finishing activities
  • Product diversions
  • Handling of returned and damaged goods
  • Complaint Handling
Security in the Supply Chain – what is expected and how Industry is approaching it
  • FMD and its role in supply security
  • How can track and trace improve supply chain security
  • What is available and how to implement

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