Type de service: Services de qualification et de validation soutenant la fabrication conforme aux BPF de médicaments, principes actifs, cosmétiques et denrées alimentaires
Norme de certification: Conforme aux directives strictes des autorités, telles que celles de l'Union européenne et de la Food and Drug Administration américaine
Compatibilité des équipements: Couvre la qualification des équipements, bâtiments et locaux, appuyée par des documents de qualification, de validation et de conformité, y compris des modèles de SOP pour des systèmes résistant aux audits

Autres informations

Description supplémentaire:

GMP-compliant manufacture of medicines, active ingredients, cosmetics, and foodstuffs is essential for market authorization and sale, and quality assurance is central since quality deviations directly affect consumer health. Meeting strict regulatory guidelines, such as those from the EU or US FDA, requires validating manufacturing processes and qualifying equipment, buildings, and premises. Chemgineering's experienced team develops customized measures to reach the required regulatory status, producing all relevant qualification, validation, and compliance documentation, including SOP templates, to build systems and processes that pass audits on the first attempt.