New EU GMP Vol.4 Annex I and Environmental Monitoring leverage
New EU GMP Vol.4 Annex I and Environmental Monitoring leverage by: Alessio […]
Tag: annex 1
Critical Utilities GMP Compliance and new Annex 1
New Annex 1, among other important points considered, dedicates several comments on the importance and the impact of Critical Utilities, involved at different level either because directly impacting on Contamination Control Strategy (CCS) document, or because potential direct or indirect source of bio-contamination of the final product.
New EU GMP Annex 1: Implications for QRM application
New EU GMP Annex 1 – Implications for QRM application by Alessio […]
2020 Annex 1 draft: new challenges for sterile manufacturers
The second draft of GMP Annex 1 has been recently released and the issue date for the new revision is finally approaching. The document, a milestone standard for all sterile manufacturers, has been widely revised and extended.