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.
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.