What makes a good RP?

Recommendation

3/4 May 2023
Vienna, Austria

The Responsible Person for Good Distribution Practice (GDP)

In a recent blog, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) discusses possibilities (and expectations) for an effective appointment and training for the Responsible Person (RP) named on the Wholesale Distribution Authorisation (WDA).

The MHRA sees a number of "key areas" an RP and its employer should consider and which MHRA "will address in turn":

• Knowledge of GDP and the relevant regulations - this is the text book stuff.
• Industry experience - relevant GDP experience.
• Familiarity with the GDP operations of the Licence Holder - particularly challenging in a large organisation.
• Induction/primary training - role familiarity.
• Role definition and place within the organisation - sufficient seniority and influence.
• Delegation and training others - The RP is responsible for all GDP activities, even those delegated.
• Training records - RP, Licence Holder and staff.
• Continuing development for the RP - the supply chain continually presents new challenges.

Source: Quelle: MHRA Inspectorate Blog "The Responsible Person named on the WDA -Part 2: Effective Appointment and Training".