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.