The Responsible Person for Good Distribution Practice (GDP)
17/18 April 2024, Hamburg, Germany
Course No. 21053
Speakers
Alfred Hunt
Hunt Pharma Solutions
Dr. Daniel Müller
GMP Inspector
Jonathan Riley
Takeda UK
Dr Torsten Schmidt-Bader
moveproTEC Compliance & Innovation Advisory
Objectives
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.
Background
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 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
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more
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Testimonials
Seminar Programme as PDF