We help you with our extensive GMP experience

-GMP-Validation / qualification according to EU-GMP (Annex 15)

-Computer Validation / qualification according to EU-GMP (Annex 11/Gamp 5 und FDA 21 CFR part 11)

-Validation/qualification for medical devices according to ISO 13485 (FDA 21 CFR Part 820)

-Creation of GMP-compliant qualification documents (DQ, IQ, OQ, PQ) for clean room, facility, HVAC, Computer System

-Design and implementation of process validation

-Preparation and execution of supplier audits (FAT)