Responsible Person according to GDP at the Logistics Service Provider

15.11.2021

LOGFILE Feature

8 min. reading time | by Simone Ferrante
Published in LOGFILE 44/2021

In Europe, companies with a wholesale distribution authorisation, the management must appoint a responsible person who is responsible for the introduction and implementation of a quality management system and compliance with the GDP rules.

A change of this person has to be notified to the competent supervisory authority.

The responsible person should fulfill their responsibilities personally and should be available at all times. The responsible person may delegate certain tasks, but not responsibilities.

The job description for the responsible person should clearly state their authority to take decisions necessary for their responsibilities. Management should give the responsible person the authority, resources and responsibilities necessary to carry out their duties.

The areas of responsibility and tasks of the responsible person must be specified in the job description and in the procedural instructions (SOPs).

The qualifications of the responsible person should be in accordance with the conditions laid down by the legislation of the Member State concerned. They should be adequate to perform the assigned tasks. A degree in pharmacy is desirable. The responsible person should have appropriate competence and experience as well as knowledge and training in GDP.

The quality management standard ISO 9001 also requires a responsible person of the management level to ensure that the requirements relating to the company's quality management system are implemented. In the past, until the revision ISO 9001:2015, this person should be called "Quality Management Representative" (QMR). Today, this name is no longer specified.

Does a logistics service provider also need a responsible person according to GDP?

If the logistics service provider does not need a wholesale distribution authorisation for its activities, then it does not have to appoint a responsible person in accordance with GDP. However, such a designation can be demanded from the client via a corresponding quality assurance agreement.

Area of responsibility of the responsible person according to GDP

The EU GDP Guidelines (2013/C 343/01) lists the area of responsibility precisely (see column 1 of the table). This can be transferred 1:1 into the job description.

Not all items in this list can be taken over by a responsible person at the logistics service provider (see column 2 of the table).

Furthermore, there are major differences for the practical implementation, depending on the size and product portfolio of the company (see column 3 of the table).

There may also be several responsible persons, especially if there are several branches. In this case, care must be taken to ensure a good demarcation of responsibilities between these persons.

The text is a translated and edited excerpt from the online knowledge portal GMP:KnowHow Pharmalogistik (GDP) which is available in German language.

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de

Simone Ferrante Written on 15 November 2021

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