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.
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.
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 responsibilities of the responsible person include the following
(excerpt from GDP (2013/C 343/01) Chapter 2.2):
|Can the responsible person at the logistics service provider (if designated) assume this responsibility?||Practical implementation|
|(i) ensuring that a quality management system is implemented and maintained;||Yes|
|(ii) focusing on the management of authorised activities and the accuracy and quality of records;||Yes||Activities should be performed in accordance with approved SOPs.
Records are to be checked on a random basis (the scope is to be determined on a risk basis).
|(iii) ensuring that initial and continuous training programmes are implemented and maintained;||Yes||Ensuring does not mean that the responsible person has to conduct all training themself. The procedure (SOP) for conducting the training programmes should be approved by them. Spot checks for monitoring (possibly only as part of the self-inspection) should be carried out (again, the scope should be determined based on risk).|
|(iv) coordinating and promptly performing any recall operations for medicinal products;||
No, because the products are no property. It can be assisted with reconciliation.Only mock recalls can be made under this responsibility.
|The performance is initiated and supervised by the responsible person or the QP. The practical performance is carried out by the returners, drivers and warehouse personnel. Only mock recalls can be performed here under this responsibility.|
|(v) ensuring that relevant customer complaints are dealt with effectively;||Yes||The respective SOP should be approved by the responsible person. The company should define what "relevant" means. There should be escalation of such complaints to the responsible person.|
|(vi) ensuring that suppliers and customers are approved;||No, this responsibility should remain with the client.||This delimitation of responsibilities should be contractually defined.|
|(vii) approving any subcontracted activities which may impact on GDP;||Yes, for the activities that are contracted out by the logistics service provider. In addition to this, depending on the contractual delimitation of responsibilities, approval from the client is also required.|
|(viii) ensuring that self-inspections are performed at appropriate regular intervals in following a prearranged programme and necessary corrective measures are put in place;||Yes||The self-inspection programme should be approved by the responsible person.|
|(ix) keeping appropriate records of any delegated duties;||Yes||
This is about the delegation of tasks in the area of responsibility of the responsible person.Job descriptions, designation documents and/or SOPs may be prepared for such evidence and signed by the responsible person and the person to whom the task is delegated.
|(x) deciding on the final disposition of returned, rejected, recalled or falsified products;||No, because the products are no property. Consequently, their whereabouts cannot be decided either.|
|(xi) approving any returns to saleable stock;||
No, because the products are no property. This may only be done on the basis of written instructions from the client.
|This delimitation of responsibilities should be contractually defined.|
|(xii) ensuring that any additional requirements imposed on certain products by national law are adhered to.||This can only be done to a limited extent, as the logistics service provider usually lacks the deeper product knowledge.||Which legal requirements apply to whom should be contractually defined.|
The text is a translated and edited excerpt from the online knowledge portal GMP:KnowHow Pharmalogistik (GDP) which is available in German language.
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