The Responsible Person in the GDP system – who is this and what are their responsibilities?

Within the Good Distribution Practice system, there is one role that cannot be delegated, replaced by a procedure or omitted from the organisational structure – the Responsible Person (RP). This requirement is unique to the pharmaceutical industry and has no equivalent in any other quality management system. Without a designated Responsible Person who meets the legal requirements, a pharmaceutical wholesaler cannot operate legally.

Formal requirements and scope of responsibilities

The Responsible Person must meet strictly defined formal requirements arising from Article 85 of the Pharmaceutical Law. A diploma, certificate or other document confirming completion of higher education in pharmacy, chemistry, medicine or related sciences within an EU Member State is required. Alternatively, other higher education qualifications are acceptable in combination with at least two years’ professional experience in the wholesale trade or quality control of medicinal products. The Responsible Person must be permanently employed – they may not perform this role as an external consultant.

The details of the Responsible Person must be reported to the Main Pharmaceutical Inspectorate and entered in the licence to operate a pharmaceutical wholesale business. Any change in the QP must be notified to the GIF without delay. In the event of the QP’s absence (illness, leave), the wholesaler must appoint a replacement meeting the same formal requirements – a break in the performance of duties without a replacement being provided constitutes a breach of the licence conditions.

The QP’s scope of responsibility covers all aspects of the wholesaler’s quality system. Key responsibilities include: ensuring the implementation of and compliance with DPD requirements, approving and overseeing quality system documentation, qualifying suppliers and customers, overseeing staff training, managing internal audits and corrective actions, overseeing the handling of returns and products suspected of being counterfeit, and liaising with pharmaceutical inspection authorities during inspections. The QM Representative signs key quality system documents, and their signature serves as formal approval of the processes carried out.

Legal liability and practical challenges

Is the Responsible Person personally liable for breaches of the DPD? Yes – and this applies to both administrative and criminal liability. The Responsible Person may be held personally liable for breaches of the DPD requirements identified by the GIF, irrespective of the company’s liability as a legal entity. In the case of serious breaches – placing counterfeit medicines on the market, breaches of storage requirements resulting in a deterioration in product quality, or the incorrect classification of suppliers – the Responsible Person may be held criminally liable under the provisions of pharmaceutical law and the Criminal Code.

Between 2020 and 2025, the Chief Pharmaceutical Inspectorate imposed a total of approximately PLN 665 million in fines in sixteen cases concerning the export or sale of medicinal products in breach of requirements. The scale of the sanctions demonstrates how seriously the regulatory authorities treat breaches in the medicines supply chain.

How does the QMS Manager manage the conflict between business requirements and the DPD? One of the most challenging aspects of the QMS Manager’s role is maintaining the independence of quality decisions in the face of commercial pressure. The GDP guidelines explicitly state that the QM must be able to make quality-related decisions without commercial interference – such as suspending a delivery, rejecting a consignment, or refusing to work with a supplier who fails to meet requirements – even if this decision results in financial losses. The organisational anchoring of this independence within the warehouse structure is one of the elements verified during GIF inspections.

What are the practical challenges in small wholesalers? In small businesses, the QM role is often combined with other responsibilities – such as warehouse manager, quality specialist or even co-owner. The DPD does not prohibit combining roles, but requires that the QM has the time and resources necessary to effectively fulfil their duties. The GIF inspection assesses the actual functioning of the quality system – if the QM is overburdened with other duties and the system operates only on a formal basis, this will be identified during the inspection. The role of the Responsible Person is effective only if it is based on a properly functioning DPD system covering all processes relating to the distribution of medicinal products.