Creating Robust Building Maintenance and Environmental Monitoring Systems for Your CGMP-Compliant Facility

by Faith Fraley, Director, CQV Engineering at Kymanox Every pharmaceutical manufacturing facility requires a controlled manufacturing environment. Temperature, humidity, and pressure are crucial to products and processes. Deviations can be disastrous, but environmental controls mean nothing if they aren’t properly qualified and validated. A programming issue with humidity controls could …

Points to Consider When Validating Computer Systems for CGMP Processes

Jim Falanga, Director, CSV Compliance Tara Doby, Sr. Validation Specialist Regulatory agencies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require life science companies to have controls on computer systems that are used to manage CGxP electronic data and records.  As part of the implementation and maintenance …