GDP Association updates Code of Practice for the Responsible Person for GDP
Recommendation
9 September 2025
Basel, Switzerland
Specifics in the Distribution of Medicinal Products
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The Code of Practice "The Responsible Person for GDP" has been revised, and Version 2 is now available for members of the European GDP Association. A task force has worked on these updates to help ensure this document continues to be a useful resource for those working in this sector.
This guidance is applicable to both large and small organisations. In any case, the role of the Responsible Person (RP), whether as a permanent member of staff or an RP providing contract services, must be tailored to individual needs and company operations. In particular, the changes include more information on the expectations of the role and responsibilities of a RP in line with increased regulatory agency focus on the RP.
Additionally, there is further guidance on data integrity expectations and more detail regarding different aspects of the role of RP where this can provide improved clarification of requirements and expectations.
Version 2 of the Code of Practice for Responsible Persons is available in the members' area of the GDP Association website.
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