Résumé
The quality of pharmaceutical products largely depends on the conditions under which they are manufactured. Therefore, environmental qualification of premises in a pharmaceutical industry is a fundamental concept to guarantee the quality, safety and effectiveness of medicines. Usually, it is a regulatory obligation and a fundamental tool in continuous improvement. Environmental qualification ensures that production rooms, equipment and processes meet defined quality standards, thereby minimizing the risk of product contamination. To demonstrate this, several tests are carried out through the phases of qualification (CQ, FAT/SAT, IQ, OQ, and PQ). This thesis illustrates these stages through a project aimed at modifying several premises and the air treatment system in a non-sterile area. Routine monitoring, which results from qualification results, is a crucial step in maintaining optimal conditions for pharmaceutical operations and detecting any deviations from established standards.