Validation du procède de fabrication : cas d'une forme orale solide

Abstract

Validation of the manufacturing process for a solid oral dosage form is a crucial step in the pharmaceutical industry to guarantee the quality, safety and efficacy of drugs. This systematic, documented process consists in demonstrating that the manufacturing process is capable of reproducibly producing products in line with pre-established specifications. It encompasses an in-depth assessment of every stage, from raw material selection to final product production, with particular emphasis on granulation, mixing, compression and, if necessary, coating. Dissolution tests, active ingredient content tests and other physico-chemical analyses are carried out to ensure formulation uniformity and homogeneity. Validation of the manufacturing process for a solid oral dosage form guarantees process stability, reproducibility of results and compliance with regulatory standards, thus ensuring the ongoing quality of pharmaceutical production.