Delta Automatisering BV
Bosmanslaan 90
7091 VW DINXPERLO

GAMP

The Gamp (Good Automated Manufacturing Practice) Guide is a guide to help users and suppliers of automated systems in / to the pharmaceutical industry to ensure that systems are developed following good practice, and to provide documentary evidence that their systems meet the agreed specifications. Pharmaceutical companies require this documentary evidence as an integral part of validation, which is defined as: "Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." - FDA Guidelines on General Principles of Process Validation.