Farmaceutische productie is onverbiddelijk. Eén mislukte EU GMP-inspectie kan de productie stilleggen, recalls veroorzaken en jaren aan herstelwerk kosten. Wij bouwen EPCM-projecten waarbij naleving van regelgeving geen eindcontrole is — maar de basis waaromheen alles is ontworpen.
De meeste farmaceutische inspectiebevindingen zijn terug te voeren op engineeringsbeslissingen die eerder in het project zijn gemaakt — niet op operationele fouten. Wij weten waar die risico's zitten, en ontwerpen ze er in een vroeg stadium uit.
URS documents that don't trace through to FAT protocols. IQ executed without reference to approved DS. OQ parameters that were never rationally derived from the FDS. We structure the entire V-model from day one so every qualification document is evidence of something that was actually tested.
ISO 14644 Grade A/B/C/D boundaries that work on paper but fail under operational pressure. Airlock cascades that don't cascade correctly. Gowning routes that create contamination vectors. We design cleanrooms for how they will actually be operated — with the operators in the design session, not just the engineers.
Software systems installed by suppliers who don't understand GAMP 5. User requirements defined after the system is already configured. CSV documentation assembled retrospectively. We validate computer systems (SCADA, DCS, MES, LIMS, ERP) prospectively — from URS to periodic review.
Factory tests run at the vendor's site that generate no IQ evidence. SAT protocols written after FAT has been "completed." We write FAT protocols that serve double duty as OQ evidence — reducing total test time by weeks and eliminating the need to rebuild the documentation package for inspectors.
Facilities that weren't designed with change control in mind cost significantly more to manage over their lifetime. We design change-managed systems — including document hierarchies, drawing revision controls, and as-built capture — as part of the initial engineering scope.
Equipment purchased without a DQ. Suppliers selected without GMP capability assessment. Delivery timelines that don't account for vendor qualification or equipment testing. We manage pharmaceutical procurement with the qualification lifecycle in view from the first specification.
We cover the full project lifecycle for pharmaceutical and biotech facilities — from site feasibility through to final qualification and handover. Every deliverable is structured around the regulatory requirements of your specific product and market.
Process plant and cleanroom design for sterile, oral solid dose, biological, and API manufacturing. EU GMP and FDA-compliant by design, not by review. HVAC, utilities, and material flow engineered to Grade requirements.
VMP development, DQ, IQ, OQ, PQ protocol writing and execution support. V-model structured from URS to PQ summary. Independent review and witness services for all qualification stages.
FAT protocol development aligned with FDS and DS. Independent technical witness at vendor sites. SAT programme coordination. Punch list management and defect resolution through to GMP release.
CSV for SCADA, DCS, MES, LIMS, ERP, and lab systems. Category 4 and 5 systems under GAMP 5. EU Annex 11 and FDA 21 CFR Part 11 compliance. Periodic review programmes.
On-site EPCM management for cleanroom construction, facility upgrades, and process installation. GMP-aware site management — your contracts, our oversight, your regulatory accountability protected.
Our fixed-scope entry product for pharma clients. We review your qualification programme before it starts — identifying gaps, clarifying the V-model structure, and defining the scope. Delivered in 5 working days. Learn more →
Of u nu een CDMO bent met doorlopende kwalificatieprogramma's, een middelgrote fabrikant die faciliteiten upgradet, of een scale-up die zijn eerste GMP-suite inbedrijfstelt — onze aanpak past zich aan uw regelgevingscontext en projectomvang aan.
Ongoing qualification, new suite fit-outs, CSV for multi-product platforms
Facility upgrades, EU GMP compliance, solid dose and liquid manufacturing
First GMP facility, VMP development, cleanroom engineering from scratch
Containment engineering, ATEX, cGMP API process plant, HAZOP support
Drie aseptische afvulsuites. Volledige V-model kwalificatie. FAT gestructureerd om direct IQ-bewijsmateriaal te genereren. EU GMP-inspectie eerste keer geslaagd.
Warehouse-naar-GMP conversie. ISO 14644-1 Class D cleanrooms. GAMP 5 gevalideerd MES. IGJ-inspectie zonder bevindingen.
Lab-naar-GMP transitie in minder dan 18 maanden. Engineering, cleanroombouw, volledige IQ/OQ voor Grade C en B suites.
The V-model isn't just a regulatory requirement — it's a project management tool. When it's done correctly, every qualification protocol is the mirror image of a design specification. Nothing is tested without a requirement. Nothing passes without traceability.
| URS | → | validates | → | PQ |
| FDS | → | validates | → | OQ |
| DS | → | validates | → | IQ |
| FAT → SAT | ||||
C2Improve writes FAT and SAT protocols that are directly traceable to the FDS and DS. This means FAT evidence is IQ/OQ evidence — tested once, not twice. For a typical equipment qualification, this saves 4–8 weeks of repeat testing and documentation.