ECA publishes Code of Practice: The Responsible Person for GDP

Recommendation

13/14 December 2023

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A Task Force initiated by the ECA Foundation has developed a Guidance document which aims to support Responsible Persons (RPs) for Good Distribution Practice (GDP). The EU Guide to Good Distribution Practice (2013/C 343/01) has defined a number of new requirements when it was published in 2013.

In Chapter 2 Personnel the GDP Guide defines requirements, responsibilities and duties of RPs. But what is expected and how can RPs show compliance with the requirements? For example the Guide defines, that "the RP should meet the qualifications and all conditions provided for by the legislation of the Member State concerned" or "The responsible person should fulfil their responsibilities personally and should be continuously contactable."

Here the Code of Practice provides information for interpretation. One section of the document provides a matrix of responsibilities for RPs, Senior Management and Authority for certain topics addressed in the EU GDP Guideline. Information is also provided for:

• External Responsible Person (Contract RPs)
• Organisational Duties to be established by the company employing the RP
• Educational Background and ongoing Training for RPs
• and basic information to design a Job Description for RPs

The Code of Practice Version 01 is available on the ECA GDP Group Webpage. The document is available at no costs after registration.