Support My Facility Project
What You Are Dealing With
You are building or expanding a GMP facility and you are managing more variables than any single team can comfortably track. Construction timelines, contractor coordination, equipment procurement, and commissioning are all running in parallel, and somewhere in the middle of all of it, every system needs to be qualified and documented to a standard the FDA can audit. The stakes are significant. A qualification gap discovered during a Pre-Approval Inspection can delay a facility startup by months and cost far more to remediate than it would have to get right during construction. The risk is not in the work you can see. It is in the gaps that only become visible when it is already expensive to fix them.
How We Approach It
We provide engineering and qualification support across the full project lifecycle. From process and bioprocess engineering through facility commissioning, HVAC and utility qualification, equipment qualification, and validation documentation, we make sure every critical system is qualified correctly and on schedule. Your team manages the build. We make sure what gets built is compliant.
What We Have Done
A biopharmaceutical startup engaged MEDVACON to oversee their facility and equipment qualification, including validation of a novel water sourcing method for their manufacturing process. MEDVACON worked alongside the client’s team and suppliers to qualify the system to cGMP standards. The facility launched in compliance and is now producing commercial batches.
A pharmaceutical company engaged MEDVACON to qualify 16 HVAC units, two facility-duty air compressors, and two dust collection systems serving GMP packaging and laboratory areas. MEDVACON developed and executed all IQ/OQ protocols and qualification reports across every system.