Gestão da qualidade na indústria farmacêutica

Abstract

The pharmaceutical industry is one of the most regulated sectors of activity, the application of a quality management system in this area requires that all processes and employees involved in the manufacture of products do not deviate from the normative standards of quality and the legal requirements imposed, for a safe production. This type of industry is governed by management standards (ISO); specific legislation (ex: Eudralex) and scientific and quality guidelines (ICH; FDA; EMA and WHO). In the case of legislation, Good Manufacturing Practices stand out as they are the reference system to ensure that pharmaceutical products are manufactured in accordance with strict internal quality standards that guarantee its safety and efficacy. The objective of this dissertation is to clarify and explain the steps for the implementation of a Quality Management System, based on the ISO 9001 Standard and the Good Manufacturing Practices described in Eudralex, as well as to better understand what quality control is and all factors involved in manufacturing a pharmaceutical product. The Implementation of a Quality Management System based on the norms ISO 9001, on the regulation Eudralex and guidelines ICH has a very positive impact as it appears that there is a contribution not only in improving the quality and management of organizations, but also in other related fields, such as efficiency and safety. In this way, the case study of this dissertation, for learning the implementation of this type of systems, is the company Stemmatters S.A, and in which it is demonstrated the application of this process in all its thoroughness and applicability to all stages of a pharmaceutical product manufacture, where an analysis of the company's management and quality control system is also carried out and where opportunities for improvement are pointed out, if any.

Date of Award	24 Feb 2023
Original language	Portuguese
Awarding Institution	Universidade Católica Portuguesa
Supervisor	Fernando Armindo da Fonseca Martins (Supervisor)