REGULATORY REQUIREMENTS AND RESPONSIBILITIES OF A QUALIFIED PERSON IN THE PHARMACEUTICAL INDUSTRY

Abstract

A Qualified Person (QP) is a person who is responsible for ensuring the safety, quality and efficacy of medicinal products throughout their entire life cycle.
Directive 2001/83/EC on medicinal products for human use represents a regulatory requirement for EU countries for delegating a role for Qualified Persons. In the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use in Chapter 2: Personnel there is a designated part of the document for the Key Personnel, where the Qualified Person belongs. Its duties and obligations are clearly stated as they are stated in the Article 51 in the Directive 2001/83/EC. In the Article 49 of the Directive 2001/83/EC is stated the qualification level as well as the necessary experience of a Qualified Person. A qualified person must hold a diploma, certificate, or other official document attesting to their formal qualifications, which must be the result of at least four years of theoretical and practical study in one of the scientific fields of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology. These fields must be recognized as equivalent by the Member State in question.
In the Republic of North Macedonia, there is also a legal obligation for the Manufacturing license holder who puts a drug on the market, to have a Qualified Person appointed. According to the Law on Medicinal Products and Medical Devices of the Republic of North Macedonia, Part III Production of Medicinal products, Article 68, every manufacturer of medicinal products should employ responsible persons for production, quality control and a qualified person for batch release with specific education requirements. This law has a requirement that the qualified person for batch release should be highly educated in the field of pharmacy and have additional knowledge in the field of production and quality control of the medicinal products. Also this person should be fully available in any part of the day and guarantee for every produced and controlled batch of the medicinal product produced by the manufacturer.
This person should have special continuous training and specific skills that help him/her in his/hers daily work. The qualified person should possess specific skills that include: Ability to make effective decisions, ability to solve problems, communication skills, ability to manage priorities and many others. The personnel professional development, especially that of qualified persons, is considered the most important element of the pharmaceutical industry and is one of the conditions for the success of their activities.
The aim of this article is to present current regulatory requirements and roles and responsibilities of a qualified persons in EU and North Macedonia.