How to implement a Quality Management System in an European pharmaceutical company in compliance with GLP, GCP and GMP/GDP guidelines

Résumé

Drug development is a significant and expensive challenge. Pharmaceuticals are lengthy, high-risk businesses committed to discovering and developing innovative, efficacious, and safe new products. The drug discovery and development process, from early development until product approval and commercialization, generally takes approximately 15 years with an average cost of 985 million of euros. Every pharmaceutical industry focuses on maintaining quality throughout the overall research and development process because quality can control other essential factors such as safety and efficacy and can decrease the cost for developing a new product. Moreover, the pharmaceutical industry is the most regulated one in the world. In the European Union, new innovative medicines can only be commercialized if they have previously received specific authorization from the competent national authorities or European Commission. So thus, quality is the most vital aspect of medicinal products and the pharmaceutical industry. A team of quality experts within a pharmaceutical company are included in the Quality Assurance (QA) department and their goal is to achieve quality through the implementation of the Quality Management System (QMS). Furthermore, a well-defined Quality Documentation System (QDS) is the base of a successful QMS. An innovative characteristic of QMS new modern approaches in the health care industry is that the quality requirements are directly imposed on the company's management system and not the product. It has also been proved that different parts of a QMS can be integrated into a single QMS using standard elements, defined as Integrated Quality Management System (IQMS). The organizational structure of the host organization where the internship has developed was used as a reference point for the description of the proposed QMS for a pharmaceutical company. The ideas described are in compliance with regulatory requirements within EU and GxP guidelines. A strictly structured Documentation System and Organizational Quality chart are the strength points of a QMS, and both are reflected in this report. The information provided related to the documentation management by specific examples and procedures is considered an important aspect of the report as the ideas are developed not only in a theoretical but also in a practical way. Additionally, the idea developed thorough this report is related to a simple and specific pharmaceutical organization. So thus, the idea is considered limited in some aspects. As a final conclusion, there is not any general QMS that could be valid for all the healthcare industries but the information described in this report could be used as a partition point for the implementation of an Integrated QMS in different organizations and pharmaceutical profiles.

la date de réponse	16 sept. 2022
langue originale	Anglais
L'institution diplômante	Universite de Namur
Superviseur	Daniela Monticielli (Jury) & Patricia Lienard (Copromoteur)