The Brief
A contract pharmaceutical manufacturer needed three new aseptic filling suites operational in 14 months to meet a vaccine supply agreement. Their previous EPCM partner had delivered late on a similar project — the commercial penalty for a repeat failure was significant.
The Challenge
The challenge wasn't just building clean rooms — it was structuring the entire qualification lifecycle so the facility would pass its first EU GMP inspection without a separate re-execution phase. Traditional approaches separate FAT from IQ, creating a 6-8 week gap where test evidence is re-generated on site. The client couldn't afford that gap.
Our Approach
We ran the full V-model qualification lifecycle from VMP through to PQ. The critical decision was structuring the FAT programme at the OEM site in Nürnberg to generate IQ evidence directly — so the test protocols at the factory mapped exactly to the qualification requirements on site. When equipment arrived in South Holland, IQ was a documentation review, not a re-execution exercise. We managed 7 equipment vendors across 4 countries, with all FAT schedules synchronised to the construction programme. The SAT programme was integrated with commissioning — not bolted on afterwards.
Results
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
"They delivered something our previous partner couldn't — an inspection-ready facility before our commercial deadline."
— VP Manufacturing