What are the Tasks and Functions of the Qualified Person (QP)?

Legal basis

Each holder of a manufacturing authorisation for medicinal products in Europe needs to name at least one Qualified Person (QP). A QP's function and responsibility is therefore unique.

The legal basis for the appointment of a QP is defined in the respective regulations and directives. The guidance clearly determine a professional's educational background and professional experience needed to act as a QP as well as the duties and responsibilities associated with this function. This European approach means that the QP is not only required to be highly qualified, but also to always have the latest information on current developments in the area of GMP/GDP and regulatory compliance. Further requirements can be found in EudraLex Vol. 4, specifically in Annex 16 and Chapter 1 (Part 1).

The EU requirements must be transferred to national law by each EU Member State. For medicinal products such requirements are typically transposed into the national law on medicinal products. The transposition may result in differences between EU Member States due to the fact that each Member State can choose the form and methods for transposing directives into national law. However, they are bound by the terms of the directive as to the result to be achieved and the deadline by which the transposition should take place. Additional requirements based on national law are also possible and do exist. These additional national requirements should not conflict with EU requirements or interfere with the free movement of goods between member states.

Responsibilities and tasks

The QP must personally ensure that the tasks listed in Annex 16, 1.6 are fulfilled:

• Certification is permitted under the terms of the MIA.
• Any additional duties and requirements of national legislation are complied with.
• Certification is recorded in a register or equivalent document.

A distinction is made between batch certification/release of finished medicinal products and confirmation of GMP compliance for intermediate products:

• Certification of the finished product batch. The certification in a register or equivalent document by a QP, as defined in Article 51 of Directive 2001/83/EC, as amended, and Article 55 of Directive 2001/82/EC, and represents the quality release of the batch before the batch is released for sale or distribution.
• Confirmation (Confirm and confirmed have equivalent meanings). A signed statement by a QP that a process or test has been conducted in accordance with GMP and the relevant marketing authorisation or clinical trial authorisation, product specification file and/or technical agreement, as applicable, as agreed in writing with the QP responsible for certifying the finished product batch before release. The QP providing a confirmation takes responsibility for those activities being confirmed.

Chapter 1, 1.7 lists a number of tasks and the QP must ensure that these are secured. These tasks can be delegated and the QP usually relies on the respective quality management systems, but the QP should have ongoing assurance that this reliance is well founded. It should be noted that the signing of a QP declaration, the batch record, the control report (Art. 97.6 of Regulation 2019/6), the batch certificate ('Certification') or the batch confirmation ('Confirmation') can only be delegated to another QP.

Chapter 1 also requires that a comprehensively designed and correctly implemented pharmaceutical quality system be in place, covering good manufacturing practice (GMP) and appropriate quality risk management. It should be fully documented and its effectiveness monitored. Similar provisions are contained in Part IV for ATMPs (Chapter 1.2).

A key requirement under Chapter 1 is to ensure that medicinal products are not sold or supplied before a QP has confirmed that the batch has been manufactured and tested in accordance with the requirements of the marketing authorisation and all other regulations. The QP should therefore be able to rely on the implementation and maintenance of the pharmaceutical quality system.
In order to perform these tasks and responsibilities, a QP needs the support of the company and its management. The following organisational measures should be implemented:

• Defined responsibility of management for the implementation, maintenance and further development of the pharmaceutical quality system.
• Access to all documents, data and information relevant to the tasks.
• Job description defining the responsibilities of the QP and the relationships with management and other responsible persons, such as the head of manufacturing and the head of quality control and, if applicable, the head of quality assurance and other QPs, including the right to issue instructions. All responsibilities that go beyond the legal obligations of the QP should be clearly identified.
• Access to the authorisation documents and information about all changes.

Qualification and continuous Training

The requirements for the continuous training of QPs are set out in Annex 16, 1.2:
"Any QP involved in the certification or confirmation of a batch must have detailed knowledge of the steps for which they are taking responsibility. The QPs should be able to prove their continuous training regarding the product type, production processes, technical advances and changes to GMP."

This continuous training can be ensured by participating in training courses, conferences and networking (e.g. ECA or the European QP Association).