The amendments to Directive 2001/83/EC, which introduce new requirements for secondary packaging, make it possible to verify the identification, authenticity and traceability of medicinal products subject to medical prescription. The importance and responsibility of the LLP in this area is to confirm the presence of these characteristics as a new legal obligation. Does this not require QP`s professional responsibility to update its knowledge in this area to ensure the quality, safety and efficacy of a drug? Q: Can a member of the quality of an EU Member State who is appointed QP by the main pharmaceutical inspectorate of the Member States and who is a chemist and not a pharmacist move to Germany and continue to perform PQ tasks? For veterinary medicinal products, the requirements set out in DIRECTIVE 2001/82/EC of the European Parliament and of the Council of 6. November 2001 on the Community code relating to veterinary medicinal products. Article 48 of Directive 2001/83 (for veterinary medicinal products, see Article 52 of Directive 2001/82) requires EU Member States to ensure that each holder of a manufacturing authorisation has at least one qualified person. 1. Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorisation has permanently and continuously at his disposal at his disposal at least one qualified person responsible, in particular, for carrying out the tasks referred to in Article 51 in accordance with Article 49. 2. If the authorisation holder personally fulfils the conditions laid down in Article 49, he may assume the responsibility referred to in paragraph 1. QP is required by law to certify in a document (set out in Appendices 1 and 2 of Annex 16) that the batch placed on the market has been manufactured and tested within the framework of national marketing requirements and legal obligations.
At the same time, any medicinal product imported from a third country must have undergone a full qualitative and quantitative analysis within the European Union (EU) of at least all active substances and all other tests necessary to confirm compliance with the marketing authorisation. Tasks and responsibilities of the qualified person Q: A company was recently inspected by the competent national supervisory authority and some of the observations of this inspection concerned the role of the qualified person in relation to the quality assurance system. For example, the Authority requested a description of the Qualified Person`s responsibility for approving controlled documents (documents in the quality assurance system). Is this required by the relevant legislation for the qualified person? A: It is a common misconception nowadays that the QP is responsible for all aspects of a quality management system, especially the approval of all types of documents, forms and reports. Although the duties and responsibilities of the qualified person are diverse, it should be clearly stated that a qualified person is not automatically the head of a quality management system, the head of quality assurance or the head of a quality control unit. This may be the case in small businesses, but very often it is not. The QP must then rely not only on the other QPs, but also on other employees and the quality system, in particular the production manager and the quality control manager. Therefore, it is an obligation to ensure that certain conditions are met, as described in Annex 16 of the EU GMP Guideline.
There is no requirement in European regulations and directives that the qualified person must approve documents other than release documentation. However, a QP should be involved in the implementation and maintenance of quality (management system). However, QP is not obliged to implement and operate the quality system. So, if a company has a quality control unit and/or a quality assurance unit with experienced and authorized employees, why should the PQ approve controlled documents? Contractually qualified persons Q: Is there a guide that defines enough time on a construction site to familiarize a quality contract with the quality system? A: There is no manual. The time spent on site depends on the complexity of the quality system. An important aspect is the maturity and stability of the system.