Tasks and Duties of the Responsible Person according to the EU GDP Guidelines

The Good Distribution Practice (GDP) sets strict requirements for the storage and distribution of medicinal products to ensure the quality and integrity of these products throughout the entire supply chain. A key role in this process is played by the Responsible Person (RP), whose duties are defined in the GDP guidelines.

Chapter 2.2 of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01) outlines twelve key tasks:

• (i) ensuring that a quality management system is implemented and maintained;
• (ii) focusing on the management of authorised activities and the accuracy and quality of records;
• (iii) ensuring that initial and continuous training programmes are implemented and maintained;
• (iv) coordinating and promptly performing any recall operations for medicinal products;
• (v) ensuring that relevant customer complaints are dealt with effectively;
• (vi) ensuring that suppliers and customers are approved;
• (vii) approving any subcontracted activities which may impact on GDP;
• (viii) ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
• (ix) keeping appropriate records of any delegated duties;
• (x) deciding on the final disposition of returned, rejected, recalled or falsified products;
• (xi) approving any returns to saleable stock;
• (xii) ensuring that any additional requirements imposed on certain products by national law are adhered to.

These responsibilities can be summarized into the following key aspects:

Ensuring GDP Compliance

The Responsible Person is tasked with ensuring that all processes within the organization adhere to GDP requirements. This includes:

• Monitoring compliance with storage and transportation conditions to maintain the quality of medicinal products,
• Implementing and maintaining a quality management system (QMS),
• Regularly conducting training sessions for employees involved in the storage and distribution of medicinal products.

Quality Oversight

Quality oversight ensures that all products leaving the company meet the necessary quality standards. This involves:

• Monitoring of deviations and risk management processes,
• Approving standard operating procedures (SOPs) and other quality-related documents,
• Ensuring that corrective and preventive actions (CAPAs) are implemented in a timely manner.

Supply Chain Management

Another critical aspect is maintaining the integrity of the supply chain. The Responsible Person:

• Reviews and approves supplier qualifications,
• Ensures that transportation complies with GDP requirements,
• Monitors the traceability of all products throughout the supply chain.

Complaint and Recall Management

The Responsible Person is the primary contact within the wholesale distributor for handling complaints and managing product recalls. Responsibilities include:

• Evaluating and documenting complaints,
• Coordinating and executing product recalls in collaboration with relevant authorities and partners.

Collaboration with Authorities

As the main contact for GDP-related matters, the Responsible Person coordinates interactions with regulatory authorities. This includes:

• Providing all necessary documents during inspections,
• Communicating GDP-relevant incidents to the appropriate authorities,
• Implementing regulatory requirements and measures.

Conclusion

The tasks of the Responsible Person are complex and require extensive expertise and a high sense of responsibility. Their role is crucial for ensuring GDP compliance.