Aplicação da ISO 9001:2015 e da Eudralex

: volume 4: Good Manufacturing Practice (GMP) guidelines em laboratório de análises físico-químicas

Abstract

According to the International Organization for Standardization (ISO), quality is defined as "the degree to which a set of characteristics meets certain requirements. In order to achieve customer satisfaction, an organization needs to provide quality products/services. To achieve this quality, a good Quality Management System (QMS) is needed. Organizations, by implementing a QMS, aim to achieve objectives related to the quality of services and products and, consequently, to maintain a high level of customer satisfaction. Certification as a quality management tool is relevant for innovation and sustainable development of a company. The NP EN ISO 9001:2015 standard is a reference for all QMS, showing the ability of an organization to provide products and services in accordance with customer requirements. Certification in this standard favors the consistency and quality of products and services provided by organizations from various sectors. EudraLex is a set of rules and standards that control medicinal products for human and veterinary use in the European Union. Volume 4 - Good Manufacturing Practices, GMP is the only volume covered in this report, and it is one of the most important. GMPs are a system that ensures that products are consistently produced and controlled to quality standards. This system is designed to minimize risks involved in any pharmaceutical production that cannot be eliminated by testing the final product. With the completion of this internship, it was possible to conclude that the ISO 9001:2015 standard requires a lot of maintenance and continuous learning. It was evident that this standard is fundamental for the organization to have the procedures and methodologies that allow a better quality management of its products and services. Regarding the GMP certification, it was possible to conclude that this standard is more specific, not giving rise to subjectivity or different interpretations of what are the good manufacturing practices.

Date of Award	3 Nov 2022
Original language	Portuguese
Awarding Institution	Universidade Católica Portuguesa
Supervisor	José António Morais Catita (Supervisor)