RP for GDP: Which Duties can be Delegated?

Recommendation

Tuesday, 30 April 2024 9 .30 - 16.45 h

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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 Personally

Duties to be performed in person include:

• focusing on the management of authorised activities and the accuracy and quality of records
• approving any subcontracted activities which may impact on GDP
• approving any returns to saleable stock
• keeping appropriate records of any delegated duties
• deciding on the final disposition of returned, rejected, recalled or falsified products

Duties that can be delegated

The tasks and activities that can be delegated in principle include:

• conducting trainings
• carrying out self-inspections
• performing recall operations for medicinal products
• handling of customer complaints
• compliance with additional requirements imposed on certain products by national law