Responsible Person for Good Distribution Practice: Designation

The EU Guide “Good Distribution Practice (GDP)” (2013/C 343/01) defines appointment of a Responsible Person for GDP as a pre-requisite for all Wholesaler Distribution Authorization (WDA) Holders. Furthermore, GDP defines:

  • Role
  • Duties
  • Responsibilities
  • Qualification
  • Recommendation for education
  • Training
  • Experience requirements of the Responsible Person (RP) for GDP.

In this article, I will discuss the requirement of GDP chapter 2 art. 2.2:

“The wholesale distributor must designate a person as responsible person.”

The wholesaler should select and qualified a person for its organization before appointing him/her as the Responsible Person for GDP.

The role of this person is defined by GDP as the key role within the company who must ensure that the entire organization performs its activities conform GDP-requirements and WDA.

This means that the person who will be appointed is suitably trained and experienced in GDP.

In doing this, the organization shall consider its size, the complexity of the GDP-activities and the product classes it manages. In small organisations that handle a limited number of products, it is generally acceptable for the WDA holder to appoint the Quality Assurance Manager as the Responsible Person for GDP. While in larger organizations, a dedicated RP can be appointed who is independent from the daily operations and has defined duties to keep a total oversight of GDP-activities.

It is possible to appoint a consultant-RP. In this case, the same level of knowledge and training in the products handled by the company and their procedures as an employed RP, is applicable. When appointing a consultant-RP, the selection process could include a confirmation of the number of other Wholesale Authorisations the potential candidate is named on, to determine whether this person will have sufficient free time and flexibility to support the operations.

To summarize: a designation of the Responsible Person for GDP is a part of the process which should be described in the GDP quality system of each wholesaler distribution authorization holder (WDA). This process shall be applied carefully whereby evidences of selection and qualification of the RP are kept properly within quality records of WDA.

In my next blog I will discuss the Role and Responsibilities as well as job description of the Responsible Person for GDP.

Kristina Bindus

• Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality & Regulatory Affairs.
• Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.
• Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.
• Kristina is specialized in online medical communication: webcast, webinar and e-learning.
• She has developed universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.
• Kristina has an extensive experience in Quality & Pharmacovigilance.