Validation d'un procédé de fabrication de comprimés pelliculés : application de l’analyse des risques et des cartes de contrôle

Abstract

The purpose of validation is to provide documented proof that a process has been developed according to the rules and that it is under control. The objective of our work is to analyze data from the initial validation and continuous verification of an industrial process for manufacturing film-coated tablets. For this, we used several tools such as risk analysis via the FMECA method and the Ishikawa or 5M diagram, the development of control charts and the process capability study. We applied these analysis techniques on data from 3 consecutive validation batches, as stipulated by GMP. For the analysis of the risks relating to the process, we took into account the steps of wet granulation, compression and film coating. The analysis of the risks relating to the product was limited to the compression and film-coating stages. The control cards concerned the following quality attributes: average mass, hardness, thickness.