The Responsible Person for Good Distribution Practice (GDP)

21/22 May 2025, Munich, Germany

Course No. 21746



Dr. Daniel Müller

Dr. Daniel Müller

GMP Inspector

Jonathan Riley

Jonathan Riley

Takeda UK

Dr Torsten Schmidt-Bader

Dr Torsten Schmidt-Bader

moveproTEC Compliance & Innovation Advisory

Alfred Hunt

Alfred Hunt

Hunt Pharma Solutions


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 Responsible Person for Good Distribution Practice (GDP)

Seminar Programme as PDF

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
What is the RP and Wholesaling
  • Qualification and experience requirements for RP
  • The Role of RP in management of export & Import
  • Annex 21: Importation of medicinal products
  • Export & import to and from EU
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
Roles and Responsibilities of the RP
  • Qualifications requirements for RPs
  • Responsible Person vs. Qualified Person
  • GDP vs. GMP
  • Duties and Delegation
  • How to discharge your duties
  • Handling of returned and damaged goods
  • Complaint Handling
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.

Security in the Supply Chain
  • Counterfeit / falsified pharmaceuticals – a real threat!
  • What is pharma industry doing about it?
  • Recent developments
  • How can track & trace support anti-counterfeiting requirements


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

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

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

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Further dates on-site
Not available
Further dates online
Further dates online
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Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

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