Sterile Fill/Finish Suite — CDMO, South Holland
A contract manufacturer needed three new aseptic filling suites operational in 14 months to meet a vaccine supply agreement. The previous EPCM partner had delivered late on a similar project — so the stakes were high. We ran the full V-model qualification lifecycle from VMP through to PQ, and structured the FAT programme at the OEM in Nürnberg to generate IQ evidence directly. That single decision eliminated a six-week re-execution phase that the previous project had needed.
6 weeks saved on qualification timeline
EU GMP inspection passed first attempt — zero critical findings, two minor observations (both documentation formatting)
Facility operational 3 months ahead of commercial deadline
12% under original budget at close-out