Checklist for Environmental Monitoring SOP Compliance
Environmental monitoring within pharmaceutical stability programs is a critical GxP activity. Properly documented and validated SOPs ensure that temperature, humidity, and light conditions remain within prescribed limits for drug product integrity. Global regulators like USFDA, EMA, and CDSCO emphasize that SOP compliance forms the backbone of stability chamber qualification. This article presents a detailed checklist…
Read More “Checklist for Environmental Monitoring SOP Compliance” »