Definition
GMP (Good Manufacturing Practice)
GMP (Good Manufacturing Practice) constitutes the general regulatory framework for pharmaceutical production. In Switzerland, the OAMéd aligns with EU GMP (Eudralex Volume 4), with Annex 11 dedicated to computerized systems and Annex 1 dedicated to sterile products (revised in 2022). We apply these principles to every pharma automation project: equipment qualification, computerized system validation, document management, change control, deviation management, material traceability, personnel training, hygiene and cross-contamination. GMP compliance is audited by Swissmedic for Swiss sites, by FDA for US exports, and by EMA authorities for the European market. A major GMP non-conformity can lead to the suspension of a product's marketing authorization.
Related
- GAMP5
- Annexe 11
- Swissmedic
- FDA
- EMA
- validation
Further reading
Pharma automation commissioning: 2026 guide
Full commissioning cycle for an automated pharma line in 2026: URS, FAT, SAT, IQ, OQ, PQ with GMP/GAMP5 and Swissmedic.
FAT/SAT pharma: hitting GMP milestones in Switzerland
Delivering successful pharma FAT/SAT in Swiss GMP sites: classic pitfalls, checklists and GAMP5-compliant validation files.
MES, ISA-95 and ERP/PLC integration in pharma: a pragmatic architecture for Swiss sites
Pharma MES architecture: the ISA-95 grid, where Werum PAS-X, Siemens Opcenter and Rockwell PharmaSuite fit, and a concrete Swiss case of perimeter re-scoping.