The GDP Responsible Person job description — the Stellenbeschreibung, as German authorities call it — is one of the first documents an inspector asks a pharmaceutical wholesale distributor for. It is not an HR formality: it is a regulatory document that defines who is personally accountable for compliance with Good Distribution Practice. In this updated guide we look at who can hold the role, the duties set out in chapter 2.2 of the EU GDP Guidelines, how requirements differ between Italy, Germany and the rest of Europe and, above all, how to build a job description template, section by section, that will stand up to any audit.
GDP Responsible Person job description: what EU legislation requires
The legal basis is Directive 2001/83/EC: Article 79(b) makes the wholesale distribution authorisation conditional on having qualified staff and, in particular, a designated responsible person. The operational requirements are detailed in the Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01): chapter 2 covers personnel and section 2.2 the Responsible Person (RP).
Three core principles must be reflected in the job description:
- Qualification: the RP must have appropriate competence and experience as well as knowledge of and training in GDP; a degree in pharmacy is "desirable" at EU level, but Member States may impose stricter requirements.
- Personal accountability: the RP must fulfil their responsibilities personally and be continuously contactable. Duties may be delegated — responsibilities never.
- Authority and resources: the company must give the RP defined authority, resources and responsibility in writing, with a clear reporting line to senior management. The guidelines state that the job description should define their authority to take decisions.
The 12 duties under section 2.2 to include in the job description
Section 2.2 lists the RP's minimum duties. A complete job description covers all of them, adapted to the activities actually authorised:
- ensuring that a quality management system is implemented and maintained;
- focusing on the management of authorised activities and the accuracy and quality of records;
- ensuring that initial and continuous training programmes are implemented and maintained;
- coordinating and promptly performing any recall operations for medicinal products;
- ensuring that relevant customer complaints are dealt with effectively;
- ensuring that suppliers and customers are approved;
- approving any subcontracted activities which may impact on GDP;
- ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
- keeping appropriate records of any delegated duties;
- deciding on the final disposition of returned, rejected, recalled or falsified products;
- approving any returns to saleable stock;
- ensuring that any additional requirements imposed on certain products by national law are adhered to.
A job description that omits even one of these points exposes the company to an almost automatic finding during an inspection.
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National requirements compared: Italy, Germany and the EU
The Directive leaves the precise qualification requirements to Member States. Anyone operating across several markets needs to know the differences:
| Scope | Reference | Requirements for the responsible person |
|---|---|---|
| European Union | GDP Guidelines 2013/C 343/01, section 2.2 | Appropriate competence and experience, GDP training; pharmacy degree "desirable"; continuous contactability; delegation of duties but not of responsibilities. |
| Italy | Legislative Decree 219/2006, Art. 101 | Degree in pharmacy, chemistry, pharmaceutical chemistry and technology or industrial chemistry; no specific criminal convictions; continuous presence at the authorised site. |
| Germany | § 52a AMG, para. 2 no. 3 | The wholesale licence application (Großhandelserlaubnis) must designate a "verantwortliche Person" with the expertise (Sachkenntnis) required for the activity; the Länder authorities expect this to be documented with qualifications and experience, and RP changes must be notified without delay. |
In the DACH region the "Stellenbeschreibung Verantwortliche Person GDP" is therefore more than a formality: it is a document the authority may examine as early as the licence application stage and at every change.
The template: the RP job description section by section
Here is the structure we recommend for the RP job description, usable as a template in any EU market:
- 1. Identification and appointment: name, qualifications, date of appointment, reference to the wholesale distribution authorisation and to the notification to the competent authority (in Germany, the designation under § 52a AMG).
- 2. Position in the organisation: place in the organisation chart (to be attached), reporting line to senior management, independence from commercial conflicts of interest.
- 3. Decision-making authority: explicit powers to block shipments, quarantine stock, approve returns, suspend suppliers and customers.
- 4. Regulatory duties: the full list of the 12 points under section 2.2, adapted to the authorised activities (import, export, brokering, cold chain).
- 5. Additional company duties: any other activity assigned to the RP (e.g. management review, change control), provided it is compatible with the role.
- 6. Delegation rules: which duties can be delegated, to whom, with which records; it must be made explicit that responsibilities remain with the RP.
- 7. Availability and deputising: how continuous contactability is ensured and the formal appointment of a qualified deputy for planned and unplanned absences.
- 8. Signatures and review: signatures of the RP and senior management with date, version number and review at every change of activities, authorisation or regulatory requirements.
The most common audit findings
Findings on the RP role almost always fall into the same categories: a generic job description copied from the guidelines without adaptation to the authorised activities; de facto delegations that are not documented (the warehouse operator who has approved returns "forever"); no deputy appointed in writing; an RP formally appointed but without real authority over quality decisions; no evidence of the RP's own continuous GDP training; a job description never updated after the authorisation was extended to new activities. All of these can be verified in minutes by cross-checking the organisation chart, the job description, the delegation SOP and the training records: better to do it internally first, during self-inspection.
GuideGxP recommendation
Treat the RP job description as a living quality system document: review it at every organisational change, align it with the activities actually authorised and link it to the delegation matrix and the training plan. Before an inspection, rehearse the auditor's three classic questions: "who decides on returning goods to saleable stock?", "how is continuous contactability ensured?", "where are delegations recorded?". If the answer is not immediate and documented, you have found your next CAPA.
To go beyond this article, our operational guide The GDP Responsible Person: a Complete Guide to Good Distribution Practice includes ready-to-use job description templates, a delegation matrix and GDP self-inspection checklists designed for anyone holding or supervising this role.
