11/12 October 2022
The area of responsibility of the Responsible Person for Good Distribution Practice (RP for GDP) is quite extensive. According to Chapter 2.2. of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01), twelve task areas (No. i to xii) are covered.
Chapter 2.2. states: "The responsible person may delegate duties but not responsibilities." In view of the rather extensive area of responsibility, the question therefore arises which tasks can be delegated if needed and which activities actually have to be performed personally.
An indication of this is the exact wording in the EU GDP Guidelines. For example, the terms "approving" and "deciding" indicate that the task in question must be performed personally.
Accordingly, the following categorization can be made:
Duties to be performed in person include:
The tasks and activities that can be delegated in principle include: