ICH Q12 analysis in the pharmaceutical industry
Pharmaceutical industry, you wish to perform an analysis according to ICH Q12
What is the ICH Q12?
Tout d’abord la guideline ICH (International Conference on Harmonisation) Q12 fournit les lignes directrices sur la gestion du cycle de vie d’un produit pharmaceutique. Il couvre toutes les étapes, de la conception à l’abandon du produit. Le laboratoire FILAB réalise l’analyse selon l’ICH Q12 pour l’industrie pharmaceutique.
Why conduct an ICH Q12 analysis?
ICH Q12 provides guidance for the implementation of the Quality by Design (QbD) approach, which involves designing for product quality from the beginning of development. It also provides principles for the management of pharmaceutical product changes, including the definition of regulatory requirements for post-approval variations. It enables the pharmaceutical industry to improve the quality, safety and efficacy of pharmaceutical products while promoting innovation and resource efficiency.
FILAB supports you in your analysis needs according to ICH Q12
Through our three levels of services: analysis, expertise and R&D support, FILAB assists companies in the pharmaceutical industry with their analysis needs according to ICH Q12. To this end, FILAB provides its clients with the know-how and experience of its team, as well as a 2100m² analytical park equipped with state-of-the-art equipment.
Our control analysis for the pharmaceutical industry
Searching for elementary impurities according to ICH Q3D
Determination of nitrosamines in pharmaceutical products
Residual solvent analysis according to USP 467 (ICH Q3C context)
Solid analysis: particle size, morphology, surface properties, etc.
Our expertise and R&D support
Problem solving: analysis of particulate contamination, odour problems, troubleshooting, etc.
Study of extractables and leachables / Stability studies
